Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-01 @ 1:49 AM
Study NCT ID:
NCT01864018
Status:
COMPLETED
Last Update Posted:
2025-07-24
First Post:
2013-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ixazomib With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'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': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'C059464', 'term': 'auricularum'}, {'id': 'C018038', 'term': 'dexamethasone acetate'}, {'id': 'C004180', 'term': 'dexamethasone 21-phosphate'}, {'id': 'C548400', 'term': 'ixazomib'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kumar.Shaji@mayo.edu', 'phone': '507-284-2511', 'title': 'Shaji Kumar', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '5 years', 'eventGroups': [{'id': 'EG000', 'title': 'Phase I/II, Cohort A', 'description': 'Questionnaire Administration: Ancillary studies', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 48, 'seriousNumAtRisk': 48, 'deathsNumAffected': 2, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Phase II, Cohort B', 'description': 'Questionnaire Administration: Ancillary studies', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 35, 'seriousNumAtRisk': 35, 'deathsNumAffected': 7, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 29, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 179, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 68, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 115, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 48, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Gastrointestinal disorders - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 138, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 66, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Edema trunk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 546, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 221, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Infections and infestations - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 5, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CD4 lymphocytes decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 25, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 138, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 296, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 40, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Lymphocyte count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 138, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 86, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 25, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 230, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hyperuricemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Musculoskeletal, conn tissue - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Neoplasms benign, mal, uncpec - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 24, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 361, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 91, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 18, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urinary frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 7, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Voice alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 34, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 70, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 7, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Gastric hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Infections and infestations - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vascular access complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Neoplasms benign, mal, uncpec - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Leukoencephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bronchial obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Resp, thoracic, mediastinal - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated (MTD) Dose of Cyclophosphamide With Ixazomib and Dexamethasone (Phase I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone)', 'description': 'INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\\> \\>\\>\n\n\\>\n\n\\>\\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Cyclophosphamide: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Dexamethasone: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Ixazomib Citrate: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Laboratory Biomarker Analysis: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Pharmacological Study: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies'}], 'classes': [{'title': 'MTD of ixazomib', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'MTD of dexamethasone', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 28 days', 'description': 'Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least 1/3 of patients, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.', 'unitOfMeasure': 'mg weekly', 'reportingStatus': 'POSTED', 'populationDescription': 'The 10 patients accrued to the phase I portion of the study were analyzed to determine the maximum tolerated dose of ixazomib with cyclophosphamide and dexamethasone'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients With Complete Response or Very Good Partial Response (Phase II, Cohort A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone)', 'description': 'INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\\> \\>\\>\n\n\\>\n\n\\>\\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Cyclophosphamide: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Dexamethasone: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Ixazomib Citrate: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Laboratory Biomarker Analysis: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Pharmacological Study: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '50'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 48 weeks', 'description': 'The percentage of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes only eligible patients in phase II, cohort A'}, {'type': 'PRIMARY', 'title': 'Rate of Complete Response, Very Good Partial Response, or Partial Response (Phase II, Cohort B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone)', 'description': 'INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\\>\\> \\>\\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\\>\\>\n\n\\>\\> Cyclophosphamide: Given PO\\>\\>\n\n\\>\\> Dexamethasone: Given PO\\>\\>\n\n\\>\\> Ixazomib Citrate: Given PO\\>\\>\n\n\\>\\> Laboratory Biomarker Analysis: Correlative studies\\>\\>\n\n\\>\\> Pharmacological Study: Correlative studies\\>\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies\\>\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '79'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 48 weeks', 'description': 'The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes only patients with biopsy proven light chain amyloidosis with organ involvement\\>\\> requiring therapy at baseline'}, {'type': 'SECONDARY', 'title': 'Number of Patients Experiencing a Grade 3 or Greater Adverse Event at Least Possibly Related to Treatment as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I/II, Cohort A', 'description': 'Patients with multiple myeloma\\>\n\n\\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Cyclophosphamide: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Dexamethasone: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Ixazomib Citrate: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Laboratory Biomarker Analysis: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Pharmacological Study: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies'}, {'id': 'OG001', 'title': 'Phase II, Cohort B', 'description': 'Patients with biopsy proven light chain amyloidosis with organ involvement\\> requiring therapy\\>\n\n\\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Cyclophosphamide: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Dexamethasone: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Ixazomib Citrate: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Laboratory Biomarker Analysis: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Pharmacological Study: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 5 years', 'description': 'The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. A grade 3 event is one that is severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I/II, Cohort A', 'description': 'Patients with multiple myeloma\\> \\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Cyclophosphamide: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Dexamethasone: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Ixazomib Citrate: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Laboratory Biomarker Analysis: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Pharmacological Study: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Patient has multiple myeloma at baseline'}, {'id': 'OG001', 'title': 'Phase II, Cohort B', 'description': 'Patients with biopsy proven light chain amyloidosis with organ involvement requiring therapy\\>\n\n\\>\n\n\\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Cyclophosphamide: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Dexamethasone: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Ixazomib Citrate: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Laboratory Biomarker Analysis: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Pharmacological Study: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Patient has light chain amyloidosis at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and upper 95% CI PFS was not reached due to the low number of progressions (11)', 'groupId': 'OG000', 'lowerLimit': '31.3', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper 95% CI PFS was not reached due to the low number of progressions (5)', 'groupId': 'OG001', 'lowerLimit': '39.6', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years', 'description': 'The distribution of PFS will be estimated using the method of Kaplan Meier.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Survival Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I/II, Cohort A', 'description': 'Patients with multiple myeloma\\> \\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Cyclophosphamide: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Dexamethasone: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Ixazomib Citrate: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Laboratory Biomarker Analysis: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Pharmacological Study: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Patient has multiple myeloma at baseline'}, {'id': 'OG001', 'title': 'Phase II, Cohort B', 'description': 'Patients with biopsy proven light chain amyloidosis with organ involvement requiring therapy\\> \\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Cyclophosphamide: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Dexamethasone: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Ixazomib Citrate: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Laboratory Biomarker Analysis: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Pharmacological Study: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Patient has light chain amyloidosis at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% CI PFS was not reached due to the low number of deaths (2)', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI PFS was not reached due to the low number of deaths (7)', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from registration to death due to any cause, assessed up to 5 years', 'description': 'The distribution of survival time will be estimated using the method of Kaplan-Meier.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pharmacokinetic (PK) Parameters', 'timeFrame': 'Post-dose, 1 and 4 hours on day 1, pre-dose on days 8, 15, and 22, and day 1 of course 2', 'description': 'Will be estimated using noncompartmental analysis methods. The plasma PK parameters calculated for individual plasma ixazomib concentration-time data will include, but are not limited to: peak concentration, time to first maximum plasma concentration, and area under the curve. PK parameters will be summarized using descriptive statistics.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life, as Assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire', 'timeFrame': 'Up to 5 years', 'description': "Patients will be evaluated by overall score at each time point and changes over time will be calculated. These measures will be correlated with outcome using Fisher's exact test and Kaplan-Meier methods where appropriate.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'Maximum Tolerated (MTD) Dose of Cyclophosphamide (Phase I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone)', 'description': 'INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\\> \\>\\>\n\n\\>\n\n\\>\\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Cyclophosphamide: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Dexamethasone: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Ixazomib Citrate: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Laboratory Biomarker Analysis: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Pharmacological Study: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '400', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 28 days', 'description': 'Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least 1/3 of patients, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.', 'unitOfMeasure': 'mg/m² weekly', 'reportingStatus': 'POSTED', 'populationDescription': 'The 10 patients accrued to the phase I portion of the study were analyzed to determine the maximum tolerated dose of ixazomib with cyclophosphamide and dexamethasone'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase I/II, Cohort A', 'description': 'Patients with Multiple Myeloma\\>\n\n\\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Cyclophosphamide: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Dexamethasone: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Ixazomib Citrate: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Laboratory Biomarker Analysis: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Pharmacological Study: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies'}, {'id': 'FG001', 'title': 'Phase II, Cohort B', 'description': 'Patients with biopsy proven light chain amyloidosis with organ involvement\\> requiring therapy\\>\n\n\\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Cyclophosphamide: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Dexamethasone: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Ixazomib Citrate: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Laboratory Biomarker Analysis: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Pharmacological Study: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Accrued During Phase I', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Accrued During Phase II', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'The phase I participants are grouped with the phase II, cohort A participants because they were grouped in the published manuscript'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase I/II, Cohort A', 'description': 'Patients with multiple myeloma\\>\n\n\\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Cyclophosphamide: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Dexamethasone: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Ixazomib Citrate: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Laboratory Biomarker Analysis: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Pharmacological Study: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies'}, {'id': 'BG001', 'title': 'Phase II, Cohort B', 'description': 'Patients with biopsy proven light chain amyloidosis with organ involvement\\> requiring therapy\\>\n\n\\> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Cyclophosphamide: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Dexamethasone: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Ixazomib Citrate: Given PO\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Laboratory Biomarker Analysis: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Pharmacological Study: Correlative studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Quality-of-Life Assessment: Ancillary studies\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'groupId': 'BG000', 'lowerLimit': '41', 'upperLimit': '88'}, {'value': '67', 'groupId': 'BG001', 'lowerLimit': '38', 'upperLimit': '78'}, {'value': '65', 'groupId': 'BG002', 'lowerLimit': '38', 'upperLimit': '88'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'ECOG Performance Status', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Grade 0 - Fully active, able to carry on all pre-disease performance without restriction\\> Grade 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work\\> Grade 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-22', 'size': 3019082, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-22T19:04', 'hasProtocol': True}, {'date': '2022-01-06', 'size': 519267, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-12-19T17:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2013-05-23', 'resultsFirstSubmitDate': '2022-07-01', 'studyFirstSubmitQcDate': '2013-05-28', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-25', 'studyFirstPostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pharmacokinetic (PK) Parameters', 'timeFrame': 'Post-dose, 1 and 4 hours on day 1, pre-dose on days 8, 15, and 22, and day 1 of course 2', 'description': 'Will be estimated using noncompartmental analysis methods. The plasma PK parameters calculated for individual plasma ixazomib concentration-time data will include, but are not limited to: peak concentration, time to first maximum plasma concentration, and area under the curve. PK parameters will be summarized using descriptive statistics.'}, {'measure': 'Quality of Life, as Assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire', 'timeFrame': 'Up to 5 years', 'description': "Patients will be evaluated by overall score at each time point and changes over time will be calculated. These measures will be correlated with outcome using Fisher's exact test and Kaplan-Meier methods where appropriate."}], 'primaryOutcomes': [{'measure': 'Maximum Tolerated (MTD) Dose of Cyclophosphamide With Ixazomib and Dexamethasone (Phase I)', 'timeFrame': 'At 28 days', 'description': 'Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least 1/3 of patients, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.'}, {'measure': 'Percentage of Patients With Complete Response or Very Good Partial Response (Phase II, Cohort A)', 'timeFrame': 'Up to 48 weeks', 'description': 'The percentage of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.'}, {'measure': 'Rate of Complete Response, Very Good Partial Response, or Partial Response (Phase II, Cohort B)', 'timeFrame': 'Up to 48 weeks', 'description': 'The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.'}, {'measure': 'Maximum Tolerated (MTD) Dose of Cyclophosphamide (Phase I)', 'timeFrame': 'At 28 days', 'description': 'Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least 1/3 of patients, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients Experiencing a Grade 3 or Greater Adverse Event at Least Possibly Related to Treatment as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0', 'timeFrame': 'Up to 5 years', 'description': 'The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. A grade 3 event is one that is severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Time from registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years', 'description': 'The distribution of PFS will be estimated using the method of Kaplan Meier.'}, {'measure': 'Survival Time', 'timeFrame': 'Time from registration to death due to any cause, assessed up to 5 years', 'description': 'The distribution of survival time will be estimated using the method of Kaplan-Meier.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Amyloidosis', 'Plasma Cell Myeloma']}, 'referencesModule': {'references': [{'pmid': '35737873', 'type': 'DERIVED', 'citation': "Muchtar E, Gertz MA, LaPlant BR, Buadi FK, Leung N, O'Brien P, Bergsagel PL, Fonder A, Hwa YL, Hobbs M, Helgeson DK, Bradt EE, Gonsalves W, Lacy MQ, Kapoor P, Siddiqui M, Larsen JT, Warsame R, Hayman SR, Go RS, Dingli D, Kourelis TV, Dispenzieri A, Rajkumar SV, Kumar SK. Phase 2 trial of ixazomib, cyclophosphamide, and dexamethasone for previously untreated light chain amyloidosis. Blood Adv. 2022 Sep 27;6(18):5429-5435. doi: 10.1182/bloodadvances.2022007781."}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This phase I/II trial studies the side effects and the best dose of cyclophosphamide when given together with ixazomib citrate and dexamethasone in treating patients with previously untreated symptomatic multiple myeloma or light chain amyloidosis. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with ixazomib citrate and dexamethasone may be a better treatment for multiple myeloma or light chain amyloidosis.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the maximum tolerated dose of cyclophosphamide that can be combined with ixazomib citrate (ixazomib) and dexamethasone in patients with previously untreated symptomatic multiple myeloma (MM). (Phase I Cohort A) II. To determine the complete plus very good partial response rate (\\>= VGPR) of ixazomib, used in combination with cyclophosphamide and dexamethasone in patients with previously untreated symptomatic MM. (Phase II Cohort A) III. To determine the hematologic response rate of ixazomib, used in combination with cyclophosphamide and dexamethasone in patients with previously untreated light chain amyloidosis. (Phase II Cohort B)\n\nSECONDARY OBJECTIVES:\n\nI. To determine the progression free survival and overall survival among patients with previously untreated symptomatic MM following treatment with ixazomib in combination with cyclophosphamide and dexamethasone followed by ixazomib maintenance till progression. (Cohort A) II. To determine the toxicities associated with ixazomib in combination with cyclophosphamide and dexamethasone in patients with previously untreated symptomatic MM. (Cohort A) III. To determine the organ response rate of ixazomib, used in combination with cyclophosphamide and dexamethasone in patients with previously untreated light chain amyloidosis. (Cohort B) IV. To determine the progression free survival and overall survival among patients with previously untreated light chain amyloidosis following treatment with ixazomib in combination with cyclophosphamide and dexamethasone followed by Ixazomib maintenance till progression. (Cohort B) V. To determine the toxicities associated with ixazomib in combination with cyclophosphamide and dexamethasone in patients with previously untreated light chain amyloidosis. (Cohort B)\n\nTERTIARY OBJECTIVES:\n\nI. To examine the pharmacokinetics of ixazomib when used in combination with cyclophosphamide and dexamethasone. (Cohort A) II. To assess the incidence of neurotoxicity using patient completed questionnaires. (Cohort A)\n\nOUTLINE: This is a phase I, dose-escalation study of cyclophosphamide followed by a phase II study.\n\nINDUCTION THERAPY: Patients receive ixazomib citrate orally (PO) on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up every 3-6 months for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* PHASE I ONLY:\n* COHORT A: multiple myeloma\n* COHORT B: biopsy proven light chain amyloidosis with organ involvement requiring therapy\n* Calculated creatinine clearance (using Cockcroft-Gault equation) \\>= 30 mL/min\n* Absolute neutrophil count (ANC) \\>= 1000/mm\\^3\n* Platelet count \\>= 75000/mm\\^3\n* Hemoglobin \\>= 8.0 g/dL\n* Total bilirubin =\\< 1.5 x upper limit of normal (ULN)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\< 3 x ULN\n* COHORT B ONLY: alkaline phosphatase =\\< 750 U/L\n* COHORT B ONLY: N-terminal pro b-type natriuretic peptide (NT-ProBNP) \\< 7500 ng/dL\n* Prior therapy for the treatment of solitary plasmacytoma is permitted, but \\> 14 days should have elapsed from the last day of radiation; NOTE: prior therapy with clarithromycin, dehydroepiandrosterone (DHEA), anakinra, pamidronate or zoledronic acid is permitted; any additional agents not listed must be approved by the principal investigator\n* Measurable disease of multiple myeloma as defined by at least ONE of the following:\n\n * Serum monoclonal protein \\>= 1.0 g/dL\n * \\> 200 mg of monoclonal protein in the urine on 24 hour electrophoresis\n * Serum immunoglobulin free light chain \\>= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\n* COHORT B ONLY: serum immunoglobulin free light chain \\>= 5 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\n* Previously untreated\n* Provide informed written consent\n* Negative pregnancy test done =\\< 7 days prior to registration, for women of childbearing potential only\n* Willing to follow strict birth control measures as suggested by the study\n\n * Female patients: if they are of childbearing potential, agree to one of the following:\n\n * Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\n * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence \\[eg, calendar, ovulation, symptothermal, post-ovulation methods\\] and withdrawal are not acceptable methods of contraception)\n * Male patients: even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\n\n * Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\n * Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\n * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence \\[eg, calendar, ovulation, symptothermal, post-ovulation methods\\] and withdrawal are not acceptable methods of contraception)\n* Willing to return to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* Monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma only\n* Prior cytotoxic chemotherapy or corticosteroids for the treatment of multiple myeloma; NOTE: prior corticosteroid use for the treatment of non-malignant disorders is permitted\n* Diagnosed or treated for another malignancy =\\< 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease; NOTE: patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection\n* Any of the following:\n\n * Pregnant women\n * Nursing women\n * Men or women of childbearing potential who are unwilling to employ adequate contraception\n* Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease\n* Other concurrent chemotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment\n* Peripheral neuropathy \\>= grade 3 on clinical examination or grade 2 with pain during the screening period\n* Major surgery =\\< 14 days prior to study registration\n* Systemic treatment with strong CYP3A4 inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital, Gingko biloba, St. John?s wort) =\\< 14 days prior to registration\n* Evidence of current uncontrolled cardiovascular conditions (New York Heart Association \\[NYHA\\] class III or IV), including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within the past 6 months; Note: prior to study entry, any electrocardiogram (ECG) abnormality at screening must be documented by the investigator as not medically relevant\n* Radiotherapy =\\< 14 days prior to registration; NOTE: if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib\n* Known human immunodeficiency virus (HIV) positive\n* Known hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection\n* Any serious medical or psychiatric illness that could, in the investigator?s opinion, potentially interfere with the completion of treatment according to this protocol\n* Known allergy to any of the study medications, their analogues or excipients in the various formulations\n* Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing\n* Diarrhea \\> grade 1, based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading, in the absence of antidiarrheals\n* Participation in clinical trials with other investigational agents not included in this trial, =\\< 30 days prior to registration"}, 'identificationModule': {'nctId': 'NCT01864018', 'briefTitle': 'Ixazomib With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Phase 1/2 Trial of Ixazomib in Combination With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis', 'orgStudyIdInfo': {'id': 'MC1382'}, 'secondaryIdInfos': [{'id': 'NCI-2013-01042', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'X16009', 'type': 'OTHER', 'domain': 'Sponsor Protocol Number'}, {'id': 'MC1382', 'type': 'OTHER', 'domain': 'Mayo Clinic'}, {'id': '13-000414', 'type': 'OTHER', 'domain': 'Mayo Clinic Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (ixazomib citrate, cyclophosphamide, dexamethasone)', 'description': 'INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Dexamethasone', 'Drug: Ixazomib Citrate', 'Other: Laboratory Biomarker Analysis', 'Other: Pharmacological Study', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['(-)-Cyclophosphamide', '2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate', 'Carloxan', 'Ciclofosfamida', 'Ciclofosfamide', 'Cicloxal', 'Clafen', 'Claphene', 'CP monohydrate', 'CTX', 'CYCLO-cell', 'Cycloblastin', 'Cycloblastine', 'Cyclophospham', 'Cyclophosphamid monohydrate', 'Cyclophosphamidum', 'Cyclophosphan', 'Cyclophosphane', 'Cyclophosphanum', 'Cyclostin', 'Cyclostine', 'Cytophosphan', 'Cytophosphane', 'Cytoxan', 'Fosfaseron', 'Genoxal', 'Genuxal', 'Ledoxina', 'Mitoxan', 'Neosar', 'Revimmune', 'Syklofosfamid', 'WR- 138719'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (ixazomib citrate, cyclophosphamide, dexamethasone)']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Aacidexam', 'Adexone', 'Aknichthol Dexa', 'Alba-Dex', 'Alin', 'Alin Depot', 'Alin Oftalmico', 'Amplidermis', 'Anemul mono', 'Auricularum', 'Auxiloson', 'Baycuten', 'Baycuten N', 'Cortidexason', 'Cortisumman', 'Decacort', 'Decadrol', 'Decadron', 'Decalix', 'Decameth', 'Decasone R.p.', 'Dectancyl', 'Dekacort', 'Deltafluorene', 'Deronil', 'Desamethasone', 'Desameton', 'Dexa-Mamallet', 'Dexa-Rhinosan', 'Dexa-Scheroson', 'Dexa-sine', 'Dexacortal', 'Dexacortin', 'Dexafarma', 'Dexafluorene', 'Dexalocal', 'Dexamecortin', 'Dexameth', 'Dexamethasonum', 'Dexamonozon', 'Dexapos', 'Dexinoral', 'Dexone', 'Dinormon', 'Fluorodelta', 'Fortecortin', 'Gammacorten', 'Hexadecadrol', 'Hexadrol', 'Lokalison-F', 'Loverine', 'Methylfluorprednisolone', 'Millicorten', 'Mymethasone', 'Orgadrone', 'Spersadex', 'Visumetazone'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (ixazomib citrate, cyclophosphamide, dexamethasone)']}, {'name': 'Ixazomib Citrate', 'type': 'DRUG', 'otherNames': ['MLN-9708', 'MLN9708', 'Ninlaro'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (ixazomib citrate, cyclophosphamide, dexamethasone)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (ixazomib citrate, cyclophosphamide, dexamethasone)']}, {'name': 'Pharmacological Study', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (ixazomib citrate, cyclophosphamide, dexamethasone)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Treatment (ixazomib citrate, cyclophosphamide, dexamethasone)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Treatment (ixazomib citrate, cyclophosphamide, dexamethasone)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Shaji Kumar, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}