Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT00963820
Status:
COMPLETED
Last Update Posted:
2018-01-10
First Post:
2009-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Evaluating the Safety and Tolerability of Weekly Dosing of Oral IXAZOMIB in Adult Patients With Relapsed and Refractory Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C548400', 'term': 'ixazomib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': "Investigator may publish clinical data after the earlier of publication by Sponsor or 12 months after early termination or database lock. Proposed publication copy should be provided to Sponsor at least 30 days prior to submission/disclosure. If requested, Sponsor's confidential information must be removed and publication delayed if Sponsor intends to file a related patent application.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose through 30 days after last dose of ixazomib citrate or until the start of subsequent antineoplastic therapy (Up to 354 days)', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Dose Escalation Cohorts', 'description': 'Ixazomib citrate, 0.24 to 3.95 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Dose Escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.', 'otherNumAtRisk': 32, 'otherNumAffected': 30, 'seriousNumAtRisk': 32, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Expansion Cohorts', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Expansion Period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.', 'otherNumAtRisk': 31, 'otherNumAffected': 31, 'seriousNumAtRisk': 31, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Blood bicarbonate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}], 'seriousEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Stenosis or Obstruction of Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Abscess Neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Parainfluenzae virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Hyperviscosity syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Multiple myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting One or More Treatment-Emergent Adverse Events and Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '0.24 mg/m^2', 'description': 'Ixazomib citrate, 0.24 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG001', 'title': '0.48 mg/m^2', 'description': 'Ixazomib citrate, 0.48 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG002', 'title': '0.80 mg/m^2', 'description': 'Ixazomib citrate, 0.80 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG003', 'title': '1.20 mg/m^2', 'description': 'Ixazomib citrate, 1.20 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG004', 'title': '1.68 mg/m^2', 'description': 'Ixazomib citrate, 1.68 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG005', 'title': '2.23 mg/m^2', 'description': 'Ixazomib citrate, 2.23 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG006', 'title': '2.97 mg/m^2', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG007', 'title': '3.95 mg/m^2', 'description': 'Ixazomib citrate, 3.95 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG008', 'title': 'Relapsed and Refractory (RR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG009', 'title': 'VELCADE-relapsed (VR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG010', 'title': 'PI naïve', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG011', 'title': 'Carfilzomib', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose through 30 days after last dose of ixazomib citrate or until the start of subsequent antineoplastic therapy (Up to 354 days)', 'description': 'An Adverse Event is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.\n\nA Serious Adverse Event (SAE) was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all randomized participants who received study drug.'}, {'type': 'SECONDARY', 'title': 'Cmax: Maximum Observed Plasma Concentration for MLN2238', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '0.24 mg/m^2', 'description': 'Ixazomib citrate, 0.24 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG001', 'title': '0.48 mg/m^2', 'description': 'Ixazomib citrate, 0.48 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG002', 'title': '0.80 mg/m^2', 'description': 'Ixazomib citrate, 0.80 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG003', 'title': '1.20 mg/m^2', 'description': 'Ixazomib citrate, 1.20 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG004', 'title': '1.68 mg/m^2', 'description': 'Ixazomib citrate, 1.68 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG005', 'title': '2.23 mg/m^2', 'description': 'Ixazomib citrate, 2.23 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG006', 'title': '2.97 mg/m^2', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG007', 'title': '3.95 mg/m^2', 'description': 'Ixazomib citrate, 3.95 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG008', 'title': 'Relapsed and Refractory (RR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG009', 'title': 'VELCADE-relapsed (VR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG010', 'title': 'PI naïve', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG011', 'title': 'Carfilzomib', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}], 'classes': [{'title': 'Cycle 1 Day 1 (n=1,1,2,1,3,2,5,4,5,8,5,3)', 'categories': [{'measurements': [{'value': '3.010', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG000'}, {'value': '2.91', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG001'}, {'value': '5.75', 'spread': '4.1083', 'groupId': 'OG002'}, {'value': '15.10', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG003'}, {'value': '13.83', 'spread': '9.7070', 'groupId': 'OG004'}, {'value': '29.05', 'spread': '11.1016', 'groupId': 'OG005'}, {'value': '65.46', 'spread': '29.3351', 'groupId': 'OG006'}, {'value': '123.95', 'spread': '79.2137', 'groupId': 'OG007'}, {'value': '75.92', 'spread': '30.3995', 'groupId': 'OG008'}, {'value': '110.43', 'spread': '62.7006', 'groupId': 'OG009'}, {'value': '77.70', 'spread': '37.9107', 'groupId': 'OG010'}, {'value': '83.73', 'spread': '87.8161', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 1 Day 15 (n=3,1,3,2,2,1,2,1,5,5,4,3)', 'categories': [{'measurements': [{'value': '3.64', 'spread': '0.9616', 'groupId': 'OG000'}, {'value': '4.64', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG001'}, {'value': '6.89', 'spread': '5.1116', 'groupId': 'OG002'}, {'value': '17.90', 'spread': '8.6267', 'groupId': 'OG003'}, {'value': '17.63', 'spread': '12.6926', 'groupId': 'OG004'}, {'value': '9.24', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG005'}, {'value': '100.55', 'spread': '15.1339', 'groupId': 'OG006'}, {'value': '134.00', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG007'}, {'value': '50.46', 'spread': '22.6877', 'groupId': 'OG008'}, {'value': '93.68', 'spread': '52.7617', 'groupId': 'OG009'}, {'value': '118.05', 'spread': '54.2907', 'groupId': 'OG010'}, {'value': '55.10', 'spread': '41.5275', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 15 of Cycle 1', 'description': 'Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Pharmacokinetic (PK) Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of Cmax.'}, {'type': 'SECONDARY', 'title': 'Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for MLN2238', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '0.24 mg/m^2', 'description': 'Ixazomib citrate, 0.24 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG001', 'title': '0.48 mg/m^2', 'description': 'Ixazomib citrate, 0.48 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG002', 'title': '0.80 mg/m^2', 'description': 'Ixazomib citrate, 0.80 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG003', 'title': '1.20 mg/m^2', 'description': 'Ixazomib citrate, 1.20 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG004', 'title': '1.68 mg/m^2', 'description': 'Ixazomib citrate, 1.68 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG005', 'title': '2.23 mg/m^2', 'description': 'Ixazomib citrate, 2.23 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG006', 'title': '2.97 mg/m^2', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG007', 'title': '3.95 mg/m^2', 'description': 'Ixazomib citrate, 3.95 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG008', 'title': 'Relapsed and Refractory (RR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG009', 'title': 'VELCADE-relapsed (VR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG010', 'title': 'PI naïve', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG011', 'title': 'Carfilzomib', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}], 'classes': [{'title': 'Cycle 1 Day 1 (n=1,1,2,1,3,2,5,4,5,8,5,3)', 'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '1.50'}, {'value': '1.53', 'groupId': 'OG001', 'lowerLimit': '1.53', 'upperLimit': '1.53'}, {'value': '1.52', 'groupId': 'OG002', 'lowerLimit': '1.03', 'upperLimit': '2.00'}, {'value': '1.00', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '1.00'}, {'value': '1.52', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.25', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '1.50'}, {'value': '1.00', 'groupId': 'OG006', 'lowerLimit': '0.50', 'upperLimit': '4.00'}, {'value': '1.00', 'groupId': 'OG007', 'lowerLimit': '0.53', 'upperLimit': '1.50'}, {'value': '2.00', 'groupId': 'OG008', 'lowerLimit': '0.50', 'upperLimit': '2.00'}, {'value': '0.50', 'groupId': 'OG009', 'lowerLimit': '0.50', 'upperLimit': '2.00'}, {'value': '1.00', 'groupId': 'OG010', 'lowerLimit': '0.50', 'upperLimit': '1.42'}, {'value': '1.42', 'groupId': 'OG011', 'lowerLimit': '1.00', 'upperLimit': '1.53'}]}]}, {'title': 'Cycle 1 Day 15 (n=3,1,3,2,2,1,2,1,5,5,4,3)', 'categories': [{'measurements': [{'value': '1.07', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '0.50'}, {'value': '1.83', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.00', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '1.00'}, {'value': '1.27', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '1.53'}, {'value': '8.00', 'groupId': 'OG005', 'lowerLimit': '8.00', 'upperLimit': '8.00'}, {'value': '1.25', 'groupId': 'OG006', 'lowerLimit': '0.50', 'upperLimit': '2.00'}, {'value': '1.03', 'groupId': 'OG007', 'lowerLimit': '1.03', 'upperLimit': '1.03'}, {'value': '1.50', 'groupId': 'OG008', 'lowerLimit': '1.00', 'upperLimit': '4.03'}, {'value': '1.00', 'groupId': 'OG009', 'lowerLimit': '0.50', 'upperLimit': '1.50'}, {'value': '1.00', 'groupId': 'OG010', 'lowerLimit': '0.50', 'upperLimit': '1.50'}, {'value': '1.03', 'groupId': 'OG011', 'lowerLimit': '1.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 15 of Cycle 1', 'description': 'Tmax: Time to reach the maximum observed plasma concentration (Cmax), equal to time to Cmax. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for analysis of Tmax.'}, {'type': 'SECONDARY', 'title': 'AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for MLN2238', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '0.24 mg/m^2', 'description': 'Ixazomib citrate, 0.24 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG001', 'title': '0.48 mg/m^2', 'description': 'Ixazomib citrate, 0.48 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG002', 'title': '0.80 mg/m^2', 'description': 'Ixazomib citrate, 0.80 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG003', 'title': '1.20 mg/m^2', 'description': 'Ixazomib citrate, 1.20 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG004', 'title': '1.68 mg/m^2', 'description': 'Ixazomib citrate, 1.68 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG005', 'title': '2.23 mg/m^2', 'description': 'Ixazomib citrate, 2.23 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG006', 'title': '2.97 mg/m^2', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG007', 'title': '3.95 mg/m^2', 'description': 'Ixazomib citrate, 3.95 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG008', 'title': 'Relapsed and Refractory (RR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG009', 'title': 'VELCADE-relapsed (VR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG010', 'title': 'PI naïve', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG011', 'title': 'Carfilzomib', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}], 'classes': [{'title': 'Cycle 1 Day 1 (n=0,0,0,0,2,1,3,4,3,5,4,3)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participants with evaluable data', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No participants with evaluable data', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No participants with evaluable data', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No participants with evaluable data', 'groupId': 'OG003'}, {'value': '258.00', 'spread': '93.3381', 'groupId': 'OG004'}, {'value': '598.00', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG005'}, {'value': '1269.67', 'spread': '429.3837', 'groupId': 'OG006'}, {'value': '1371.25', 'spread': '725.1939', 'groupId': 'OG007'}, {'value': '1793.33', 'spread': '507.6744', 'groupId': 'OG008'}, {'value': '854.20', 'spread': '330.0745', 'groupId': 'OG009'}, {'value': '750.25', 'spread': '312.3890', 'groupId': 'OG010'}, {'value': '813.67', 'spread': '262.5649', 'groupId': 'OG011'}]}]}, {'title': 'Cycle 1 Day 15 (n=0,0,2,0,2,1,2,1,1,4,3,2)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participants with evaluable data', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No participants with evaluable data', 'groupId': 'OG001'}, {'value': '398.50', 'spread': '45.9616', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No participants with evaluable data', 'groupId': 'OG003'}, {'value': '663.00', 'spread': '142.8356', 'groupId': 'OG004'}, {'value': '868.00', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG005'}, {'value': '3100.00', 'spread': '834.3860', 'groupId': 'OG006'}, {'value': '1460.00', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG007'}, {'value': '3690.00', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG008'}, {'value': '1777.75', 'spread': '958.4767', 'groupId': 'OG009'}, {'value': '1549.00', 'spread': '1027.6930', 'groupId': 'OG010'}, {'value': '2075.00', 'spread': '1025.3048', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 15 of Cycle 1', 'description': 'AUC(0-168) is a measure of the area under the plasma concentration-time curve over the dosing interval (tau) (AUC\\[0-tau\\]), where tau is the length of the dosing interval - 168 hours in this study). MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of AUC(0-168).'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio: Day 15 AUC0-168 / Day 1 AUC0-168 for MLN2238', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '0.24 mg/m^2', 'description': 'Ixazomib citrate, 0.24 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG001', 'title': '0.48 mg/m^2', 'description': 'Ixazomib citrate, 0.48 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG002', 'title': '0.80 mg/m^2', 'description': 'Ixazomib citrate, 0.80 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG003', 'title': '1.20 mg/m^2', 'description': 'Ixazomib citrate, 1.20 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG004', 'title': '1.68 mg/m^2', 'description': 'Ixazomib citrate, 1.68 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG005', 'title': '2.23 mg/m^2', 'description': 'Ixazomib citrate, 2.23 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG006', 'title': '2.97 mg/m^2', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG007', 'title': '3.95 mg/m^2', 'description': 'Ixazomib citrate, 3.95 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG008', 'title': 'Relapsed and Refractory (RR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG009', 'title': 'VELCADE-relapsed (VR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG010', 'title': 'PI naïve', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG011', 'title': 'Carfilzomib', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.64', 'spread': '0.3960', 'groupId': 'OG004'}, {'value': '1.45', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG005'}, {'value': '2.25', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG006'}, {'value': '1.19', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG007'}, {'value': '2.25', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG008'}, {'value': '2.19', 'spread': '0.8228', 'groupId': 'OG009'}, {'value': '1.97', 'spread': '0.5869', 'groupId': 'OG010'}, {'value': '2.37', 'spread': '0.2192', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 of Cycle 1', 'description': 'MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).', 'unitOfMeasure': 'unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of accumulation ratio.'}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Rate Constant (λz) for MLN2238', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '0.24 mg/m^2', 'description': 'Ixazomib citrate, 0.24 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG001', 'title': '0.48 mg/m^2', 'description': 'Ixazomib citrate, 0.48 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG002', 'title': '0.80 mg/m^2', 'description': 'Ixazomib citrate, 0.80 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG003', 'title': '1.20 mg/m^2', 'description': 'Ixazomib citrate, 1.20 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG004', 'title': '1.68 mg/m^2', 'description': 'Ixazomib citrate, 1.68 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG005', 'title': '2.23 mg/m^2', 'description': 'Ixazomib citrate, 2.23 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG006', 'title': '2.97 mg/m^2', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG007', 'title': '3.95 mg/m^2', 'description': 'Ixazomib citrate, 3.95 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG008', 'title': 'Relapsed and Refractory (RR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG009', 'title': 'VELCADE-relapsed (VR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG010', 'title': 'PI naïve', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG011', 'title': 'Carfilzomib', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.000', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG002'}, {'value': '0.000', 'spread': '0.0001', 'groupId': 'OG003'}, {'value': '0.000', 'spread': '0.0003', 'groupId': 'OG004'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG005'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG006'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG007'}, {'value': '0.00', 'spread': '0.0019', 'groupId': 'OG008'}, {'value': '0.00', 'spread': '0.0014', 'groupId': 'OG009'}, {'value': '0.01', 'spread': '0.0019', 'groupId': 'OG010'}, {'value': '0.01', 'spread': '0.0003', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 of Cycle 1', 'description': 'Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body and the values were used for calculation of T1/2. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).', 'unitOfMeasure': '1/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of terminal elimination rate constant.'}, {'type': 'SECONDARY', 'title': 'Terminal Phase Elimination Half-life (T1/2) for MLN2238', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '0.24 mg/m^2', 'description': 'Ixazomib citrate, 0.24 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG001', 'title': '0.48 mg/m^2', 'description': 'Ixazomib citrate, 0.48 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG002', 'title': '0.80 mg/m^2', 'description': 'Ixazomib citrate, 0.80 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG003', 'title': '1.20 mg/m^2', 'description': 'Ixazomib citrate, 1.20 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG004', 'title': '1.68 mg/m^2', 'description': 'Ixazomib citrate, 1.68 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG005', 'title': '2.23 mg/m^2', 'description': 'Ixazomib citrate, 2.23 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG006', 'title': '2.97 mg/m^2', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG007', 'title': '3.95 mg/m^2', 'description': 'Ixazomib citrate, 3.95 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG008', 'title': 'Relapsed and Refractory (RR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG009', 'title': 'VELCADE-relapsed (VR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG010', 'title': 'PI naïve', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG011', 'title': 'Carfilzomib', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}], 'classes': [{'categories': [{'measurements': [{'value': '271.00', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG002'}, {'value': '190.50', 'spread': '7.7782', 'groupId': 'OG003'}, {'value': '189.00', 'spread': '12.7279', 'groupId': 'OG004'}, {'value': '175.00', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG005'}, {'value': '246.00', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG006'}, {'value': '165.00', 'spread': 'NA', 'comment': 'Can not be calculated for 1 participant.', 'groupId': 'OG007'}, {'value': '186.00', 'spread': '84.8528', 'groupId': 'OG008'}, {'value': '202.33', 'spread': '63.0899', 'groupId': 'OG009'}, {'value': '123.90', 'spread': '39.4620', 'groupId': 'OG010'}, {'value': '108.00', 'spread': '4.2426', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 of Cycle 1', 'description': 'Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of terminal phase elimination half-life.'}, {'type': 'SECONDARY', 'title': 'Emax: Maximum Inhibition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '0.24 mg/m^2', 'description': 'Ixazomib citrate, 0.24 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG001', 'title': '0.48 mg/m^2', 'description': 'Ixazomib citrate, 0.48 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG002', 'title': '0.80 mg/m^2', 'description': 'Ixazomib citrate, 0.80 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG003', 'title': '1.20 mg/m^2', 'description': 'Ixazomib citrate, 1.20 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG004', 'title': '1.68 mg/m^2', 'description': 'Ixazomib citrate, 1.68 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG005', 'title': '2.23 mg/m^2', 'description': 'Ixazomib citrate, 2.23 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG006', 'title': '2.97 mg/m^2', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG007', 'title': '3.95 mg/m^2', 'description': 'Ixazomib citrate, 3.95 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG008', 'title': 'Relapsed and Refractory (RR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG009', 'title': 'VELCADE-relapsed (VR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG010', 'title': 'PI naïve', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG011', 'title': 'Carfilzomib', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported", 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported", 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported", 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported", 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported", 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported", 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported", 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported", 'groupId': 'OG008'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported", 'groupId': 'OG009'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported", 'groupId': 'OG010'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported", 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 15 of Cycle 1', 'description': 'A Whole Blood 20S Proteasome Inhibition Parameter. There were no subjects in the Pharmacodynamic (PD) Analysis Set for the 2.23 mg/m\\^2 cohort, so PD tables do not include that arm.', 'unitOfMeasure': 'Percentage of inhibition', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD analysis Population included all participants who had sufficient dosing data to calculate PD parameters'}, {'type': 'SECONDARY', 'title': 'TEmax: Time of Occurrence of Emax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '0.24 mg/m^2', 'description': 'Ixazomib citrate, 0.24 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG001', 'title': '0.48 mg/m^2', 'description': 'Ixazomib citrate, 0.48 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG002', 'title': '0.80 mg/m^2', 'description': 'Ixazomib citrate, 0.80 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG003', 'title': '1.20 mg/m^2', 'description': 'Ixazomib citrate, 1.20 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG004', 'title': '1.68 mg/m^2', 'description': 'Ixazomib citrate, 1.68 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG005', 'title': '2.23 mg/m^2', 'description': 'Ixazomib citrate, 2.23 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG006', 'title': '2.97 mg/m^2', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG007', 'title': '3.95 mg/m^2', 'description': 'Ixazomib citrate, 3.95 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG008', 'title': 'Relapsed and Refractory (RR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG009', 'title': 'VELCADE-relapsed (VR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG010', 'title': 'PI naïve', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG011', 'title': 'Carfilzomib', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported.", 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported.", 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported.", 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported.", 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported.", 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported.", 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported.", 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported.", 'groupId': 'OG008'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported.", 'groupId': 'OG009'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported.", 'groupId': 'OG010'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to concerns about the third-party laboratory's performance of the 20S assay, accuracy of the data cannot be considered reliable, and therefore, is not being reported.", 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 15 of Cycle 1', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD analysis population included all participants who had sufficient dosing data to calculate PD parameters'}, {'type': 'SECONDARY', 'title': "Overall Response to Treatment With Ixazomib Citrate Based on Investigator's Evaluation Over Time", 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '0.24 mg/m^2', 'description': 'Ixazomib citrate, 0.24 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG001', 'title': '0.48 mg/m^2', 'description': 'Ixazomib citrate, 0.48 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG002', 'title': '0.80 mg/m^2', 'description': 'Ixazomib citrate, 0.80 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG003', 'title': '1.20 mg/m^2', 'description': 'Ixazomib citrate, 1.20 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG004', 'title': '1.68 mg/m^2', 'description': 'Ixazomib citrate, 1.68 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG005', 'title': '2.23 mg/m^2', 'description': 'Ixazomib citrate, 2.23 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG006', 'title': '2.97 mg/m^2', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG007', 'title': '3.95 mg/m^2', 'description': 'Ixazomib citrate, 3.95 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG008', 'title': 'Relapsed and Refractory (RR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG009', 'title': 'VELCADE-relapsed (VR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG010', 'title': 'PI naïve', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG011', 'title': 'Carfilzomib', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}], 'classes': [{'title': 'CR + PR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '25', 'groupId': 'OG006', 'lowerLimit': '0', 'upperLimit': '81'}, {'value': '25', 'groupId': 'OG007', 'lowerLimit': '0', 'upperLimit': '81'}, {'value': '9', 'groupId': 'OG008', 'lowerLimit': '0', 'upperLimit': '41'}, {'value': '22', 'groupId': 'OG009', 'lowerLimit': '3', 'upperLimit': '60'}, {'value': '17', 'groupId': 'OG010', 'lowerLimit': '0', 'upperLimit': '64'}, {'value': '25', 'groupId': 'OG011', 'lowerLimit': '0', 'upperLimit': '81'}]}]}, {'title': 'CR + PR + MR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '25', 'groupId': 'OG006', 'lowerLimit': '0', 'upperLimit': '81'}, {'value': '25', 'groupId': 'OG007', 'lowerLimit': '0', 'upperLimit': '81'}, {'value': '18', 'groupId': 'OG008', 'lowerLimit': '2', 'upperLimit': '52'}, {'value': '33', 'groupId': 'OG009', 'lowerLimit': '7', 'upperLimit': '70'}, {'value': '17', 'groupId': 'OG010', 'lowerLimit': '0', 'upperLimit': '64'}, {'value': '25', 'groupId': 'OG011', 'lowerLimit': '0', 'upperLimit': '81'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 354 days', 'description': 'Responses were based on International Myeloma Working Group Uniform Criteria. Complete Response (CR)=Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \\<5% plasma cells in bone marrow.\n\nPartial Response (PR)= reduction in M-Protein ≥50% in serum and ≥90% in 24-hour urine. If M-protein unmeasurable, ≥50% decrease in difference of involved and uninvolved Free Light Chain (FLC). If M-protein and FLC unmeasurable, ≥50% reduction in plasma cells is required, if baseline bone marrow plasma cell ≥30%. And ≥50% reduction in the size of soft tissue plasmacytomas.\n\nMinimal Response (MR)= 25-49% reduction in serum paraprotein for 6 weeks. 50-89% reduction in 24 hour urinary light chain excretion for 6 weeks. For Non-secretory myeloma patients, 25-49 % reduction in plasma cells in bone marrow and trephine biopsy for a 6 weeks. 25-49% reduction in the size of soft tissue plasmacytomas. No increase in the size or number of lytic bone lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-Evaluable Population included all participants who had measurable disease at Baseline, had received at least 1 dose of study drug, and had at least 1 post-baseline response assessment.'}, {'type': 'PRIMARY', 'title': 'Neurotoxicity Grading', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': '0.24 mg/m^2', 'description': 'Ixazomib citrate, 0.24 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG001', 'title': '0.48 mg/m^2', 'description': 'Ixazomib citrate, 0.48 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG002', 'title': '0.80 mg/m^2', 'description': 'Ixazomib citrate, 0.80 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG003', 'title': '1.20 mg/m^2', 'description': 'Ixazomib citrate, 1.20 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG004', 'title': '1.68 mg/m^2', 'description': 'Ixazomib citrate, 1.68 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG005', 'title': '2.23 mg/m^2', 'description': 'Ixazomib citrate, 2.23 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG006', 'title': '2.97 mg/m^2', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG007', 'title': '3.95 mg/m^2', 'description': 'Ixazomib citrate, 3.95 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG008', 'title': 'Relapsed and Refractory (RR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG009', 'title': 'VELCADE-relapsed (VR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG010', 'title': 'PI naïve', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'OG011', 'title': 'Carfilzomib', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}], 'classes': [{'title': 'Cycle 1 Day 1 (n=2,3,3,3,4,3,7,4,9,8,6,4)', 'categories': [{'measurements': [{'value': '36.00', 'spread': '9.899', 'groupId': 'OG000'}, {'value': '40.33', 'spread': '1.155', 'groupId': 'OG001'}, {'value': '42.00', 'spread': '3.464', 'groupId': 'OG002'}, {'value': '36.00', 'spread': '7.937', 'groupId': 'OG003'}, {'value': '39.50', 'spread': '2.646', 'groupId': 'OG004'}, {'value': '36.80', 'spread': '4.530', 'groupId': 'OG005'}, {'value': '33.14', 'spread': '7.841', 'groupId': 'OG006'}, {'value': '38.50', 'spread': '4.203', 'groupId': 'OG007'}, {'value': '38.44', 'spread': '5.053', 'groupId': 'OG008'}, {'value': '33.73', 'spread': '6.935', 'groupId': 'OG009'}, {'value': '38.00', 'spread': '6.928', 'groupId': 'OG010'}, {'value': '32.00', 'spread': '8.367', 'groupId': 'OG011'}]}]}, {'title': 'End of Study (n=3,3,2,1,1,3,4,3,8,5,4,3)', 'categories': [{'measurements': [{'value': '25.00', 'spread': '3.606', 'groupId': 'OG000'}, {'value': '40.67', 'spread': '2.517', 'groupId': 'OG001'}, {'value': '38.50', 'spread': '3.536', 'groupId': 'OG002'}, {'value': '35.00', 'spread': '0.000', 'groupId': 'OG003'}, {'value': '42.00', 'spread': '0.000', 'groupId': 'OG004'}, {'value': '36.00', 'spread': '3.606', 'groupId': 'OG005'}, {'value': '36.00', 'spread': '7.528', 'groupId': 'OG006'}, {'value': '33.33', 'spread': '8.386', 'groupId': 'OG007'}, {'value': '33.88', 'spread': '9.219', 'groupId': 'OG008'}, {'value': '27.24', 'spread': '13.122', 'groupId': 'OG009'}, {'value': '37.00', 'spread': '5.944', 'groupId': 'OG010'}, {'value': '27.33', 'spread': '7.371', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 and End of Study (Up to 354 days)', 'description': 'Neurotoxicity is graded using participant responses to 11 functional questions on a 5-point scale, where 0=Not at all and 4=Very much, using the Functional Assessment of Cancer Therapy/Gynecology Oncology Group - Neurotoxicity Questionnaire, Version 4.0(14). Neurotoxicity subscale is a sum of 11 reversed item scores where each original score is transformed as (4 - score). The highest possible score is 44, and a higher score indicates more neurotoxicity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all randomized participants who received study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0.24 mg/m^2', 'description': 'Ixazomib citrate, 0.24 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'FG001', 'title': '0.48 mg/m^2', 'description': 'Ixazomib citrate, 0.48 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'FG002', 'title': '0.80 mg/m^2', 'description': 'Ixazomib citrate, 0.80 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'FG003', 'title': '1.20 mg/m^2', 'description': 'Ixazomib citrate, 1.20 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'FG004', 'title': '1.68 mg/m^2', 'description': 'Ixazomib citrate, 1.68 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'FG005', 'title': '2.23 mg/m^2', 'description': 'Ixazomib citrate, 2.23 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'FG006', 'title': '2.97 mg/m^2', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'FG007', 'title': '3.95 mg/m^2', 'description': 'Ixazomib citrate, 3.95 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'FG008', 'title': 'Relapsed and Refractory (RR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established Maximum Tolerated Dose (MTD), capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'FG009', 'title': 'VELCADE-relapsed (VR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'FG010', 'title': 'PI naïve', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}, {'id': 'FG011', 'title': 'Carfilzomib', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.'}], 'periods': [{'title': 'Dose Escalation Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'comment': 'Expansion cohorts were not part of Dose Escalation except as noted in comments.', 'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Unsatisfactory Therapeutic Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}, {'title': 'Expansion Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Dose escalation cohorts were not part of the Expansion Phase except as noted in comments.', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'comment': 'Includes 2 participants from the dose escalation cohort 2.97 mg/m\\^2.', 'groupId': 'FG008', 'numSubjects': '11'}, {'comment': 'Includes 1 participant from the dose escalation cohort 2.97 mg/m\\^2.', 'groupId': 'FG009', 'numSubjects': '10'}, {'comment': 'Includes only participants who are proteasome inhibitor (PI)-naïve.', 'groupId': 'FG010', 'numSubjects': '6'}, {'comment': 'Includes participants with last dose of carfilzomib 21 to 60 days before 1st ixazomib citrate dose.', 'groupId': 'FG011', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'comment': 'Participant was ongoing at the time of data cut off for analysis', 'groupId': 'FG008', 'numSubjects': '1'}, {'comment': 'Participant was ongoing at the time of data cut off for analysis', 'groupId': 'FG009', 'numSubjects': '1'}, {'comment': 'Participant was ongoing at the time of data cut off for analysis', 'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '10'}, {'groupId': 'FG009', 'numSubjects': '9'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '8'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '1'}]}, {'type': 'Unsatisfactory Therapeutic Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Sixty (60) participants took part in the study at 6 investigative sites in the United States from 31 October 2009 to database lock on 28 February 2013.', 'preAssignmentDetails': 'Participants with a diagnosis of multiple myeloma (relapsed and/or refractory) were enrolled in the dose escalation phase to determine maximum tolerated dose (MTD). Once the MTD was established, participants were enrolled at the MTD into 1 of the 4 expansion cohorts.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'Safety Population'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'spread': '9.10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '168.4', 'spread': '9.34', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Height data was missing for 1 participant. Mean and standard deviation calculation is based on 59 participants.', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '83.26', 'spread': '18.106', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Surface Area at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '1.96', 'spread': '0.247', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Body Surface Area (BSA) was missing for 1 participant. Mean and standard deviation are based on 59 participants.', 'unitOfMeasure': 'm^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety Population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-12', 'studyFirstSubmitDate': '2009-08-20', 'resultsFirstSubmitDate': '2015-05-29', 'studyFirstSubmitQcDate': '2009-08-21', 'lastUpdatePostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-07-30', 'studyFirstPostDateStruct': {'date': '2009-08-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting One or More Treatment-Emergent Adverse Events and Serious Adverse Events', 'timeFrame': 'From the first dose through 30 days after last dose of ixazomib citrate or until the start of subsequent antineoplastic therapy (Up to 354 days)', 'description': 'An Adverse Event is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.\n\nA Serious Adverse Event (SAE) was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.'}, {'measure': 'Neurotoxicity Grading', 'timeFrame': 'Cycle 1 Day 1 and End of Study (Up to 354 days)', 'description': 'Neurotoxicity is graded using participant responses to 11 functional questions on a 5-point scale, where 0=Not at all and 4=Very much, using the Functional Assessment of Cancer Therapy/Gynecology Oncology Group - Neurotoxicity Questionnaire, Version 4.0(14). Neurotoxicity subscale is a sum of 11 reversed item scores where each original score is transformed as (4 - score). The highest possible score is 44, and a higher score indicates more neurotoxicity.'}], 'secondaryOutcomes': [{'measure': 'Cmax: Maximum Observed Plasma Concentration for MLN2238', 'timeFrame': 'Days 1 and 15 of Cycle 1', 'description': 'Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).'}, {'measure': 'Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for MLN2238', 'timeFrame': 'Days 1 and 15 of Cycle 1', 'description': 'Tmax: Time to reach the maximum observed plasma concentration (Cmax), equal to time to Cmax. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).'}, {'measure': 'AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for MLN2238', 'timeFrame': 'Days 1 and 15 of Cycle 1', 'description': 'AUC(0-168) is a measure of the area under the plasma concentration-time curve over the dosing interval (tau) (AUC\\[0-tau\\]), where tau is the length of the dosing interval - 168 hours in this study). MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).'}, {'measure': 'Accumulation Ratio: Day 15 AUC0-168 / Day 1 AUC0-168 for MLN2238', 'timeFrame': 'Day 15 of Cycle 1', 'description': 'MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).'}, {'measure': 'Terminal Elimination Rate Constant (λz) for MLN2238', 'timeFrame': 'Day 15 of Cycle 1', 'description': 'Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body and the values were used for calculation of T1/2. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).'}, {'measure': 'Terminal Phase Elimination Half-life (T1/2) for MLN2238', 'timeFrame': 'Day 15 of Cycle 1', 'description': 'Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).'}, {'measure': 'Emax: Maximum Inhibition', 'timeFrame': 'Days 1 and 15 of Cycle 1', 'description': 'A Whole Blood 20S Proteasome Inhibition Parameter. There were no subjects in the Pharmacodynamic (PD) Analysis Set for the 2.23 mg/m\\^2 cohort, so PD tables do not include that arm.'}, {'measure': 'TEmax: Time of Occurrence of Emax', 'timeFrame': 'Days 1 and 15 of Cycle 1'}, {'measure': "Overall Response to Treatment With Ixazomib Citrate Based on Investigator's Evaluation Over Time", 'timeFrame': 'Up to 354 days', 'description': 'Responses were based on International Myeloma Working Group Uniform Criteria. Complete Response (CR)=Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \\<5% plasma cells in bone marrow.\n\nPartial Response (PR)= reduction in M-Protein ≥50% in serum and ≥90% in 24-hour urine. If M-protein unmeasurable, ≥50% decrease in difference of involved and uninvolved Free Light Chain (FLC). If M-protein and FLC unmeasurable, ≥50% reduction in plasma cells is required, if baseline bone marrow plasma cell ≥30%. And ≥50% reduction in the size of soft tissue plasmacytomas.\n\nMinimal Response (MR)= 25-49% reduction in serum paraprotein for 6 weeks. 50-89% reduction in 24 hour urinary light chain excretion for 6 weeks. For Non-secretory myeloma patients, 25-49 % reduction in plasma cells in bone marrow and trephine biopsy for a 6 weeks. 25-49% reduction in the size of soft tissue plasmacytomas. No increase in the size or number of lytic bone lesions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Relapsed multiple myeloma', 'Refractory multiple myeloma', 'Drug therapy'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '28803351', 'type': 'DERIVED', 'citation': 'Gupta N, Yang H, Hanley MJ, Zhang S, Liu R, Kumar S, Richardson PG, Skacel T, Venkatakrishnan K. Dose and Schedule Selection of the Oral Proteasome Inhibitor Ixazomib in Relapsed/Refractory Multiple Myeloma: Clinical and Model-Based Analyses. Target Oncol. 2017 Oct;12(5):643-654. doi: 10.1007/s11523-017-0524-3.'}, {'pmid': '24904120', 'type': 'DERIVED', 'citation': 'Kumar SK, Bensinger WI, Zimmerman TM, Reeder CB, Berenson JR, Berg D, Hui AM, Gupta N, Di Bacco A, Yu J, Shou Y, Niesvizky R. Phase 1 study of weekly dosing with the investigational oral proteasome inhibitor ixazomib in relapsed/refractory multiple myeloma. Blood. 2014 Aug 14;124(7):1047-55. doi: 10.1182/blood-2014-01-548941. Epub 2014 Jun 5.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the safety profile, tolerability, and maximum tolerated dose of ixazomib citrate (MLN9708) when taken orally on a weekly dosing schedule by patients with relapsed and refractory multiple myeloma (RRMM). Secondary objectives include pharmacokinetics and response rates.', 'detailedDescription': 'The drug being tested in this study is called ixazomib citrate (MLN9708). Ixazomib citrate is being tested for people who have multiple myeloma who have relapsed after treatment or become unresponsive to treatment.\n\nThis study will determine the maximum tolerated dose (MTD) of ixazomib citrate using a dose escalation scheme. Once MTD is established, participants will be enrolled at MTD into one of the 4 expansion cohorts to characterize the safety, tolerability and efficacy of MLN9708. Blood samples for safety labs, hematology, serum chemistry and pharmacokinetic evaluations will be obtained at the timepoints specified. Disease response assessment is to be performed on the first day of every other cycle beginning with Cycle 3.\n\nThe study will enroll approximately 60 patients. All participants will receive treatment with ixazomib citrate. This multi-center trial will be conducted in the United States. The overall time to participate in this study is up to 60 days, and participants will make 12-16 visits to the clinic for study procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nEach patient must meet all of the following eligibility criteria to be enrolled in the study:\n\n* Adult patients with multiple myeloma who have relapsed following at least 2 lines of therapy.\n* Patients must have measurable disease.\n* Appropriate functional status, including the recovery from the effects of prior antineoplastic therapy, and acceptable organ function as described in the protocol.\n* Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.\n* Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse.\n* Willing and able to give written informed consent.\n* Suitable venous access for study-required blood sampling.\n\nExclusion Criteria:\n\n* Peripheral neuropathy that is greater or equal to Grade 2.\n* Major surgery or, serious infections, or infections that required systemic antibiotic therapy within 14 days before the first dose of study drug.\n* Life-threatening illness unrelated to cancer.\n* Diarrhea that is greater than Grade 1 as outlined in the protocol\n* Systemic antineoplastic or radiation therapy within 14 days or cytotoxic agents, or treatment with any investigational products within 21 days before the first dose of study treatment.\n* Treatment with any investigational proteasome inhibitor.\n* Systemic treatment with prohibited medications that are outlined in the protocol within 14 days of study treatment.\n* Ongoing therapy with corticosteroids greater than 10mg of prednisone or its equivalent per day.\n* Central nervous system involvement.\n* Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months.\n* Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.\n* Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.\n* Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption of tolerance of IXAZOMIB including difficulty swallowing."}, 'identificationModule': {'nctId': 'NCT00963820', 'briefTitle': 'Study Evaluating the Safety and Tolerability of Weekly Dosing of Oral IXAZOMIB in Adult Patients With Relapsed and Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'An Open-Label, Dose-Escalation, Phase 1 Study Evaluating the Safety and Tolerability of Weekly Dosing of the Oral Form of MLN9708, a Second-Generation Proteasome Inhibitor, in Adult Patients With Relapsed and Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'C16004'}, 'secondaryIdInfos': [{'id': 'U1111-1166-8401', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.24 mg/m^2', 'description': 'Ixazomib citrate, 0.24 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate', 'interventionNames': ['Drug: Ixazomib citrate']}, {'type': 'EXPERIMENTAL', 'label': '0.48 mg/m^2', 'description': 'Ixazomib citrate, 0.48 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.', 'interventionNames': ['Drug: Ixazomib citrate']}, {'type': 'EXPERIMENTAL', 'label': '0.80 mg/m^2', 'description': 'Ixazomib citrate, 0.80 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.', 'interventionNames': ['Drug: Ixazomib citrate']}, {'type': 'EXPERIMENTAL', 'label': '1.20 mg/m^2', 'description': 'Ixazomib citrate, 1.20 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period.', 'interventionNames': ['Drug: Ixazomib citrate']}, {'type': 'EXPERIMENTAL', 'label': '1.68 mg/m^2', 'description': 'Ixazomib citrate, 1.68 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.', 'interventionNames': ['Drug: Ixazomib citrate']}, {'type': 'EXPERIMENTAL', 'label': '2.23 mg/m^2', 'description': 'Ixazomib citrate, 2.23 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.', 'interventionNames': ['Drug: Ixazomib citrate']}, {'type': 'EXPERIMENTAL', 'label': '2.97 mg/m^2', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.', 'interventionNames': ['Drug: Ixazomib citrate']}, {'type': 'EXPERIMENTAL', 'label': '3.95 mg/m^2', 'description': 'Ixazomib citrate, 3.95 mg/m\\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.', 'interventionNames': ['Drug: Ixazomib citrate']}, {'type': 'EXPERIMENTAL', 'label': 'Relapsed and Refractory (RR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established Maximum Tolerated Dose (MTD), capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.', 'interventionNames': ['Drug: Ixazomib citrate']}, {'type': 'EXPERIMENTAL', 'label': 'VELCADE-Relapsed (VR)', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.', 'interventionNames': ['Drug: Ixazomib citrate']}, {'type': 'EXPERIMENTAL', 'label': 'PI naïve', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.', 'interventionNames': ['Drug: Ixazomib citrate']}, {'type': 'EXPERIMENTAL', 'label': 'Carfilzomib', 'description': 'Ixazomib citrate, 2.97 mg/m\\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.', 'interventionNames': ['Drug: Ixazomib citrate']}], 'interventions': [{'name': 'Ixazomib citrate', 'type': 'DRUG', 'otherNames': ['MLN9708'], 'description': 'Ixazomib citrate capsules', 'armGroupLabels': ['0.24 mg/m^2', '0.48 mg/m^2', '0.80 mg/m^2', '1.20 mg/m^2', '1.68 mg/m^2', '2.23 mg/m^2', '2.97 mg/m^2', '3.95 mg/m^2', 'Carfilzomib', 'PI naïve', 'Relapsed and Refractory (RR)', 'VELCADE-Relapsed (VR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic- Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90069', 'city': 'West Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'James R. Berenson, MD, Inc', 'geoPoint': {'lat': 34.09001, 'lon': -118.36174}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill-Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Millennium Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Millennium Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}