Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2026-03-06 @ 5:57 PM
Study NCT ID:
NCT02812706
Status:
COMPLETED
Last Update Posted:
2024-04-01
First Post:
2016-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients
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': 'C000599209', 'term': 'isatuximab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '6#', 'organization': 'Sanofi aventis recherche & développement'}, 'certainAgreement': {'otherDetails': 'The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AE data was collected from first dose of study drug up to 30 days after last dose of study drug administration (maximum duration of exposure: up to 112 weeks for Cohort 1, and 137 weeks for Cohort 2 for Phase 1 part; and up to 248 weeks for Phase 2 part)', 'description': 'All-Cause Mortality data collected during the study was assessed for all enrolled participants. Serious and Other Adverse Events were collected for safety population only (i.e., all participants who gave their informed consent and received at least one dose \\[even incomplete\\] of isatuximab).', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1, Cohort 1: Isatuximab 10 mg/kg', 'description': 'Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Phase 1, Cohort 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Phase 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 24, 'seriousNumAtRisk': 28, 'deathsNumAffected': 10, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hand-Foot-And-Mouth Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Infected Dermal Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 17, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rhinitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Upper Respiratory Tract Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Periodontal Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dermatitis Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Bone Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pathological Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Chest Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 12, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Platelet Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Infusion Related Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Disseminated Intravascular Coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Large Intestine Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Disease Progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Anal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Intervertebral Discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lung Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diabetic Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Osteonecrosis Of Jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Synovial Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Gastrointestinal Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Subarachnoid Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Thrombotic Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Neurogenic Bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1, Cohort 1: Isatuximab 10 mg/kg', 'description': 'Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Phase 1, Cohort 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 (28 days)', 'description': 'DLTs: AEs occurring during 1st treatment cycle, assessed per national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 4.03. DLTs included: Hematologic DLTs: Grade(G) 4 neutropenia(N) lasting greater than or equal to (\\>=) 5 days; G3 to G4 N with fever or microbiologically or radiographically documented infection; G4 thrombocytopenia lasting for \\>=5 days; thrombocytopenia, treatment delay greater than (\\>)14 days due to hematologic toxicity. Non-hematologic DLTs: G\\>=3 non-hematological AE, excluding G3 fatigue, G 3 to 4 electrolyte abnormalities, G3 nausea/vomiting/diarrhea if responsive to optimal medical management within 48 hours or allergic reaction/ hypersensitivity attributed to isatuximab; AE that required treatment delay for \\>14 days. Any other toxicity deemed by Investigator or sponsor to be dose-limiting, regardless of the grade, was also considered DLT.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on DLT evaluable population that included subset of participants who completed the first Cycle which consisted of 4 isatuximab administrations of the study drug or they discontinued study drug before completion of first cycle for a DLT.\n\n.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Percentage of Participants With Overall Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable adverse events, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of the first response until the primary analysis data cut-off date of 31 July 2018 (median duration of follow-up was 24.14 weeks)', 'description': 'Percentage of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) assessed by International Myeloma Working Group (IMWG) uniform response criteria. sCR: CR as defined plus normal FLC ratio \\& absence of clonal cells in bone marrow. CR: negative immunofixation on serum \\& urine; disappearance of any soft tissue plasmacytomas; \\<5% plasma cells in bone marrow; normal FLC ratio of 0.26-1.65. VGPR: serum \\& urine M-protein detectable by immunofixation; \\>=90% reduction in serum M-protein plus urine M-protein level \\<100 mg/24 h; \\>90% decrease in difference between involved \\& uninvolved FLC levels required. PR: \\>=50% reduction of serum M-protein \\& reduction in 24h urinary M protein by \\>=90%/\\<200 mg/24 h; if serum \\& urine M-protein unmeasurable:\\>=50% decrease in difference between involved \\& uninvolved FLC; if serum \\& urine M-protein not measurable:\\>=50% reduction in plasma cells required, in place of M-protein.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all treated population.'}, {'type': 'SECONDARY', 'title': 'Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1, Cohort 1: Isatuximab 10 mg/kg', 'description': 'Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Phase 1, Cohort 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to 30 days after the last dose of study drug administration (maximum duration of exposure: up to 112 weeks for Cohort 1 and 137 weeks for Cohort 2)', 'description': 'An AE was defined as any untoward medical occurrence in a participant or clinical investigation patient administered with a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TESAEs was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that develop, worsened or became serious during the on-treatment period (time from first dose of study drug up to 30 days after the last dose of study drug administration).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all treated population.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to 30 days after the last dose of study drug administration (maximum duration of exposure: up to 248 weeks)', 'description': 'An AE was defined as any untoward medical occurrence in a participant or clinical investigation patient administered with a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. TESAEs was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs are defined as AEs that develop, worsened or became serious during the on-treatment period (time from first dose of study drug up to 30 days after the last dose of study drug administration).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all treated population.'}, {'type': 'SECONDARY', 'title': 'Phase 1: Percentage of Participants With Overall Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1, Cohort 1: Isatuximab 10 mg/kg', 'description': 'Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Phase 1, Cohort 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of the first response until disease progression, or death due to any cause, whichever comes first (maximum duration of exposure: up to 112 weeks for Cohort 1 and 137 weeks for Cohort 2)', 'description': 'Percentage of participants with sCR, CR, VGPR, and PR assessed by IMWG uniform response criteria. sCR: CR as defined plus normal FLC ratio \\& absence of clonal cells in bone marrow. CR: negative immunofixation on serum \\& urine; disappearance of any soft tissue plasmacytomas; \\<5 percentage (%) plasma cells in bone marrow; normal FLC ratio of 0.26-1.65. VGPR: serum \\& urine M-protein detectable by immunofixation; \\>=90% reduction in serum M-protein plus urine M-protein level \\<100 mg/24 hour (h); \\>90% decrease in difference between involved \\& uninvolved FLC levels required. PR: \\>=50% reduction of serum M-protein \\& reduction in 24h urinary M protein by \\>=90%/\\<200 mg/24 h; if serum \\& urine M-protein unmeasurable:\\>=50% decrease in difference between involved \\& uninvolved FLC; if serum \\& urine M-protein not measurable:\\>=50% reduction in plasma cells required, in place of M-protein.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all treated population.'}, {'type': 'SECONDARY', 'title': 'Phase 1: Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1, Cohort 1: Isatuximab 10 mg/kg', 'description': 'Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Phase 1, Cohort 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '100.64', 'spread': '7.78', 'groupId': 'OG000'}, {'value': '113.90', 'spread': '18.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the date of the first response until disease progression, or death due to any cause, whichever comes first (maximum duration of exposure: up to 112 weeks for Cohort 1 and 137 weeks for Cohort 2)', 'description': 'DOR: time (in weeks) from date of first response to date of subsequent progressive disease (PD) or death, whichever happens earlier. In absence of confirmation of subsequent PD or death before cut-off date, DOR was censored at date of last valid assessment performed or date of initiation of new anticancer treatment, whichever was earlier. PD (IMWG criteria): increase (inc.) of \\>=25% from lowest response value in any one of following: serum M-component (absolute inc.\\>=0.5 g/dL) and/or; urine M-component (absolute inc.\\>=200 mg/24h) and/or, in participants without measurable serum \\& urine M-protein: difference between involved \\& uninvolved FLC levels (absolute inc. \\>10 mg/dL); in participants without measurable serum \\& urine M-protein and without measurable disease by FLC levels, bone marrow plasma cell % (absolute % \\>=10%); development of new bone lesions or soft tissue plasmacytomas/definite inc. in size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on a subset of participants who had response.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Percentage of Participants With Clinical Benefit (CB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of first study treatment administration until first documented response, or death due to any cause, whichever comes first (maximum duration of exposure: up to 248 weeks)', 'description': 'CB defined as percentage of participants with sCR, CR, VGPR, PR or Minor/minimal response (MR) assessed by IMWG criteria. sCR: CR as defined plus normal FLC ratio \\& absence of clonal cells. CR: negative immunofixation on serum \\& urine; disappearance of any soft tissue plasmacytomas; \\<5% plasma cells in bone marrow; normal FLC ratio: 0.26-1.65. VGPR: serum \\& urine M-protein detectable by immunofixation; \\>=90% reduction in serum M-protein plus urine M-protein level \\<100 mg/24h; \\>90% decrease in difference between involved \\& uninvolved FLC levels required. PR: \\>=50% reduction of serum M-protein \\& reduction in 24h urinary M protein by \\>=90%/\\<200 mg/24 h; if serum \\& urine M-protein unmeasurable:\\>=50% decrease in difference between involved \\& uninvolved FLC; if serum \\& urine M-protein not measurable:\\>=50% reduction in plasma cells required. MR: \\>=25% but \\<=49% reduction of serum M protein and reduction in 24h urine M protein by 50-89%; 25-49% reduction in size of soft tissue plasmacytomas.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all treated population. Data for this outcome measure was not planned to be collected and analyzed for Phase 1.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and upper limit of 95% confidence interval (CI) was not estimable due to the smaller number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '20.24', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of first study treatment administration to the date of death due to any cause (maximum duration of exposure: up to 248 weeks)', 'description': 'Overall survival was defined as the time interval (in months) from the date of first study treatment administration to death due to any cause. In the absence of the confirmation of death before the cut-off date, OS was censored at the last date the participant was known to be alive or at the study cut-off date, whichever was earlier. Analysis was performed by Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all treated population. Data for this outcome measure was not planned to be collected and analyzed for Phase 1.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '3.75', 'upperLimit': '12.98'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of first study treatment administration until disease progression or death due to any cause, whichever comes first (maximum duration of exposure: up to 248 weeks)', 'description': 'PFS was defined as the time interval (in months) from date of first study treatment administration until disease progression or death due to any cause, whichever comes first. In absence of PD or death, PFS was censored at date of last valid assessment performed before cut-off date or date of initiation of new anticancer treatment, whichever was earlier. PD (IMWG criteria): inc. of \\>=25% in any one of following: serum M-component absolute (abs.) inc. \\>=0.5 g/dL) and/or; urine M-component (abs. inc. \\>=200 mg/24h) and/or, in participants without measurable serum \\& urine M-protein, difference between involved \\& uninvolved FLC levels (abs. inc. \\>10 mg/dL); in participants without measurable serum \\& urine M-protein \\& without measurable disease by FLC levels: bone marrow plasma cell % (abs. % \\>=10%); definite development of new bone lesions or soft tissue plasmacytomas or definite inc. in size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all treated population. Analysis was performed by Kaplan-Meier method. Data for this outcome measure was not planned to be collected and analyzed for Phase 1.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '58.70', 'spread': '29.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the date of first response until disease progression, or death due to any cause, whichever comes first (maximum duration of exposure: up to 248 weeks)', 'description': 'DOR was defined as time (in weeks) from date of first response to date of subsequent progressive disease (PD) or death, whichever happens earlier. In absence of confirmation of subsequent PD or death before cut-off date, DOR was censored at date of last valid assessment performed or date of initiation of new anticancer treatment, whichever was earlier. PD (IMWG criteria):inc. of \\>=25% from lowest response value in any one of following: serum M-component (absolute inc.\\>=0.5 g/dL) and/or; urine M-component (absolute inc.\\>=200 mg/24h) and/or, in participants without measurable serum \\& urine M-protein: difference between involved \\& uninvolved FLC levels (absolute inc.\\>10 mg/dL); in participants without measurable serum \\& urine M-protein and without measurable disease by FLC levels, bone marrow plasma cell % (absolute% \\>=10%); development of new bone lesions or soft tissue plasmacytomas/definite inc. in size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on a subset of participants who had response.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Time to Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '3.745', 'upperLimit': '12.977'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of first study treatment administration until disease progression, or death due to any cause, whichever comes first (maximum duration of exposure: up to 248 weeks)', 'description': 'TTP: time interval (in months) from date of first study treatment administration to date of first assessed disease progression. In absence of disease progression, TTP was censored at date of last valid assessment performed before cut-off date or date of initiation of new anticancer treatment, whichever was earlier. PD (IMWG criteria): inc. of \\>=25% from lowest response value in any one of following: serum M-component (absolute inc.\\>=0.5 g/dL) and/or; urine M-component (absolute inc.\\>=200 mg/24h) and/or, in participants without measurable serum \\& urine M-protein: difference between involved \\& uninvolved FLC levels (absolute inc.\\>10 mg/dL); in participants without measurable serum \\& urine M-protein and without measurable disease by FLC levels, bone marrow plasma cell % (absolute% \\>=10%); development of new bone lesions or soft tissue plasmacytomas/definite inc. in size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all treated population. Analysis was performed by Kaplan-Meier method. Data for this outcome measure was not planned to be collected and analyzed for Phase 1.'}, {'type': 'SECONDARY', 'title': 'Phase 1: Plasma Concentration Observed at the End of Intravenous Infusion (Ceoi) of Isatuximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1, Cohort 1: Isatuximab 10 mg/kg', 'description': 'Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Phase 1, Cohort 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '122', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '246', 'spread': '51.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of infusion on Day 1 of Cycle 1', 'description': 'Ceoi is the plasma concentration observed at the end of intravenous infusion.', 'unitOfMeasure': 'micrograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK population that included all participants who gave their informed consent and received at least one dose (even incomplete) of Isatuximab; with data for at least 1 PK parameter available. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Phase 1: Maximum Observed Concentration (Cmax) After First Infusion of Isatuximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1, Cohort 1: Isatuximab 10 mg/kg', 'description': 'Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Phase 1, Cohort 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '124', 'spread': '22.9', 'groupId': 'OG000'}, {'value': '280', 'spread': '64.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 at 0 hour (pre-dose), mid-infusion (2 hours post-infusion), end of infusion (EOI) and EOI+4-hour, Day 2 (24 hour), Day 3 (48 hour), Day 4 (72 hour) and pre-dose on Day 8 (0 hour)', 'description': 'Cmax was defined as the maximum concentration observed after the first infusion calculated using the non-compartmental analysis.', 'unitOfMeasure': 'micrograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK population. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Phase 1: Time to Reach the Maximum Concentration (Tmax) After First Infusion of Isatuximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1, Cohort 1: Isatuximab 10 mg/kg', 'description': 'Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Phase 1, Cohort 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.68', 'groupId': 'OG000', 'lowerLimit': '2.32', 'upperLimit': '7.25'}, {'value': '5.56', 'groupId': 'OG001', 'lowerLimit': '3.28', 'upperLimit': '8.48'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 at 0 hour (pre-dose), mid-infusion (2 hours post-infusion), EOI and EOI+4-hour, Day 2 (24 hour), Day 3 (48 hour), Day 4 (72 hour) and pre-dose on Day 8 (0 hour)', 'description': 'Tmax was defined as the time to reach Cmax, calculated using the non-compartmental analysis after the intravenous infusion.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK population. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Phase 1: Area Under the Plasma Concentration Versus Curve Over the Dosing Interval (AUC1-week) After First Infusion of Isatuximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1, Cohort 1: Isatuximab 10 mg/kg', 'description': 'Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Phase 1, Cohort 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '9300', 'spread': '3010', 'groupId': 'OG000'}, {'value': '21300', 'spread': '5520', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 at 0 hour (pre-dose), mid-infusion (2 hours post-infusion), EOI and EOI+4-hour, Day 2 (24 hour), Day 3 (48 hour), Day 4 (72 hour) and pre-dose on Day 8 (0 hour)', 'description': 'AUC was defined as area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval.', 'unitOfMeasure': 'micrograms*hours per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK population. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Phase 1: Trough Plasma Concentrations (Ctrough) of Isatuximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1, Cohort 1: Isatuximab 10 mg/kg', 'description': 'Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Phase 1, Cohort 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).'}], 'classes': [{'title': 'Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.77', 'spread': '8.98', 'groupId': 'OG000'}, {'value': '78.52', 'spread': '38.49', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.33', 'spread': '22.87', 'groupId': 'OG000'}, {'value': '186.33', 'spread': '69.29', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '124.87', 'spread': '69.51', 'groupId': 'OG000'}, {'value': '254.00', 'spread': '97.45', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '135.57', 'spread': '125.10', 'groupId': 'OG000'}, {'value': '367.75', 'spread': '127.45', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '167.80', 'spread': '154.43', 'groupId': 'OG000'}, {'value': '419.08', 'spread': '351.57', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '174.40', 'spread': '184.70', 'groupId': 'OG000'}, {'value': '500.98', 'spread': '426.78', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '193.50', 'spread': '154.86', 'groupId': 'OG000'}, {'value': '347.75', 'spread': '259.68', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '202.85', 'spread': '172.75', 'groupId': 'OG000'}, {'value': '344.30', 'spread': '286.74', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '184.85', 'spread': '182.65', 'groupId': 'OG000'}, {'value': '392.63', 'spread': '322.70', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '220.40', 'spread': '228.54', 'groupId': 'OG000'}, {'value': '608.00', 'spread': '351.93', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '233.00', 'spread': '237.59', 'groupId': 'OG000'}, {'value': '581.33', 'spread': '356.35', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '267.50', 'spread': '280.72', 'groupId': 'OG000'}, {'value': '665.67', 'spread': '385.34', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '160.60', 'spread': '116.53', 'groupId': 'OG000'}, {'value': '714.33', 'spread': '451.44', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '200.15', 'spread': '165.25', 'groupId': 'OG000'}, {'value': '611.67', 'spread': '342.27', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '254.50', 'spread': '228.40', 'groupId': 'OG000'}, {'value': '641.67', 'spread': '246.78', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '303.00', 'spread': '278.60', 'groupId': 'OG000'}, {'value': '874.67', 'spread': '408.85', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '242.50', 'spread': '88.39', 'groupId': 'OG000'}, {'value': '789.67', 'spread': '525.08', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '269.00', 'spread': '147.08', 'groupId': 'OG000'}, {'value': '722.67', 'spread': '379.50', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 9 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '444.00', 'spread': '463.86', 'groupId': 'OG000'}, {'value': '758.33', 'spread': '393.20', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '436.50', 'spread': '441.94', 'groupId': 'OG000'}, {'value': '941.67', 'spread': '576.67', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '684.00', 'spread': '772.16', 'groupId': 'OG000'}, {'value': '1224.67', 'spread': '719.96', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 11 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '592.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-infusion on Cycle 1 Day 8 (C1 D8), C1 D15, C1 D22, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15, C5 D1, C5 D15, C6 D1, C6 D15, C7 D1, C7 D15, C8 D1, C8 D15, C9 D1, C9 D15, C10 D1, C10 D15, C11 D1', 'description': 'Ctrough was the plasma concentration observed just before treatment administration during repeated dosing.', 'unitOfMeasure': 'micrograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK population. Here, "Number analyzed" = participants with available data for each specified category and "0" in the number analyzed field signifies that no participants were available for analysis at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Maximum Observed Concentration (Cmax) After First Infusion of Isatuximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '747.83', 'spread': '743.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Multiple timepoints from Cycle 1 to Cycle 10', 'description': 'Cmax was predicted using population pharmacokinetic model.', 'unitOfMeasure': 'micrograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK population. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Area Under the Plasma Concentration Versus Curve Over the Dosing Interval (AUC1-Week) After First Infusion of Isatuximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '65071', 'spread': '55554', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Multiple timepoints from Cycle 1 to Cycle 10', 'description': 'AUC was predicted using population pharmacokinetic model.', 'unitOfMeasure': 'micrograms * hours per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK population. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Trough Plasma Concentrations (Ctrough) of Isatuximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).'}], 'classes': [{'title': 'Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '376.34', 'spread': '666.40', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '662.52', 'spread': '1283.39', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '604.17', 'spread': '996.78', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '927.63', 'spread': '1194.16', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '826.15', 'spread': '958.75', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '734.39', 'spread': '675.85', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '689.85', 'spread': '715.21', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '723.76', 'spread': '802.83', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '619.35', 'spread': '356.21', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '647.24', 'spread': '338.97', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '683.90', 'spread': '391.48', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '674.20', 'spread': '439.78', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '742.93', 'spread': '420.34', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '733.83', 'spread': '373.26', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 7 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '786.27', 'spread': '331.38', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '870.09', 'spread': '443.79', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 8 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1004.00', 'spread': '463.82', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '946.25', 'spread': '369.91', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 9 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '878.63', 'spread': '313.39', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '823.75', 'spread': '314.95', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 10 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '845.38', 'spread': '322.48', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-infusion on C1 D8, C1 D15, C1 D22, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15, C5 D1, C5 D15, C6 D1, C6 D15, C7 D1, C7 D15, C8 D1, C8 D15, C9 D1, C9 D15, C10 D1, C10 D15', 'description': 'Ctrough was the plasma concentration observed just before treatment administration during repeated dosing.', 'unitOfMeasure': 'micrograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK population. Here, "Number analyzed" = participants with available data for each specified category.'}, {'type': 'SECONDARY', 'title': 'Phase 1 and 2: CD38 Receptor Density at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-responder', 'description': 'Participants treated with Isatuximab, with independent adjudication committee assessment response \\<PR.'}, {'id': 'OG001', 'title': 'Responder', 'description': 'Participants treated with Isatuximab, with independent adjudication committee assessment response \\>=PR.'}], 'classes': [{'categories': [{'measurements': [{'value': '113226.2', 'spread': '93628.7', 'groupId': 'OG000'}, {'value': '133378.2', 'spread': '55518.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline (Day 1)', 'description': "CD38 receptor density assessed from bone marrow aspirates for responder and non-responders' participants was reported.", 'unitOfMeasure': 'sMEC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Participants treated with Isatuximab (Phase 1 and 2) and evaluable for CD38 receptor density assessment. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Phase 1: Number of Participants With Anti-drug Antibodies (ADA) Response Against Isatuximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1, Cohort 1: Isatuximab 10 mg/kg', 'description': 'Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).'}, {'id': 'OG001', 'title': 'Phase 1, Cohort 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).'}], 'classes': [{'title': 'Treatment-induced ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment boosted ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to 30 days after last study drug administration (maximum duration of exposure: up to 112 weeks for Cohort 1, and 137 weeks for Cohort 2)', 'description': 'ADA were categorized as: treatment induced, and treatment boosted response. Treatment-induced ADA: ADA that developed at any time during the ADA on-study observation period in participants without preexisting ADA (ADA that was present in samples drawn during the ADA pretreatment period). Treatment boosted ADA: Preexisting ADA with an increase in titer value between pretreatment \\& posttreatment samples of at least two titer steps, during the ADA on-study observation period.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ADA population which included all participants that received isatuximab in Phase 1 part of the study, with at least one ADA assessment reportable during the ADA on-study observation periods.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Number of Participants With Anti-drug Antibodies (ADA) Response Against Isatuximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).'}], 'classes': [{'title': 'Treatment-induced ADA', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Treatment boosted ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to 30 days after last study drug administration (maximum duration of exposure: up to 248 weeks)', 'description': 'ADA were categorized as: treatment induced, and treatment boosted response. Treatment-induced ADA: ADA that developed at any time during the ADA on-study observation period in participants without preexisting ADA (ADA that was present in samples drawn during the ADA pretreatment period). Treatment boosted ADA: Preexisting ADA with an increase in titer value between pretreatment \\& posttreatment samples of at least two titer steps, during the ADA on-study observation period.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on ADA population which included all participants that received isatuximab in Phase 2 part of the study, with at least one ADA assessment reportable during the ADA on-study observation periods.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1, Cohort 1: Isatuximab 10 mg/kg', 'description': 'Participants received Isatuximab 10 milligram per kilogram (mg/kg) intravenous (IV) infusion once every week (QW) for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then every 2 weeks (Q2W) (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable adverse events (AEs), disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).'}, {'id': 'FG001', 'title': 'Phase 1, Cohort 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).'}, {'id': 'FG002', 'title': 'Phase 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).'}], 'periods': [{'title': 'Phase 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'comment': 'Phase 1 and Phase 2 were separate populations.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Phase 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Phase 1 and Phase 2 were separate populations', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Phase 1 and Phase 2 were separate populations.', 'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'Other-Unspecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The study was conducted at 13 centers in Japan. A total of 36 participants were enrolled between 05 September 2016 and 6 April 2018, and received isatuximab monotherapy.', 'preAssignmentDetails': 'Study consisted of 2 phases: Phase 1 and Phase 2. Phase I (Cohorts 1 and 2) was a dose escalation part to evaluate the safety, pharmacokinetics (PK), and efficacy of isatuximab. Phase 2 was commenced after completion of the DLT observation period in Phase 1 and determination of the recommended dose to be used in Phase 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1, Cohort 1: Isatuximab 10 mg/kg', 'description': 'Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).'}, {'id': 'BG001', 'title': 'Phase 1, Cohort 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).'}, {'id': 'BG002', 'title': 'Phase 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.3', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '74.4', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '70.6', 'spread': '8.1', 'groupId': 'BG002'}, {'value': '70.9', 'spread': '7.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on all treated population which included all participants who gave their informed consent and received at least one dose (even incomplete) of isatuximab.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-15', 'size': 2555707, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-31T10:32', 'hasProtocol': True}, {'date': '2018-08-30', 'size': 936273, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-31T10:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-26', 'studyFirstSubmitDate': '2016-06-22', 'resultsFirstSubmitDate': '2023-09-26', 'studyFirstSubmitQcDate': '2016-06-22', 'lastUpdatePostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-26', 'studyFirstPostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Cycle 1 (28 days)', 'description': 'DLTs: AEs occurring during 1st treatment cycle, assessed per national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 4.03. DLTs included: Hematologic DLTs: Grade(G) 4 neutropenia(N) lasting greater than or equal to (\\>=) 5 days; G3 to G4 N with fever or microbiologically or radiographically documented infection; G4 thrombocytopenia lasting for \\>=5 days; thrombocytopenia, treatment delay greater than (\\>)14 days due to hematologic toxicity. Non-hematologic DLTs: G\\>=3 non-hematological AE, excluding G3 fatigue, G 3 to 4 electrolyte abnormalities, G3 nausea/vomiting/diarrhea if responsive to optimal medical management within 48 hours or allergic reaction/ hypersensitivity attributed to isatuximab; AE that required treatment delay for \\>14 days. Any other toxicity deemed by Investigator or sponsor to be dose-limiting, regardless of the grade, was also considered DLT.'}, {'measure': 'Phase 2: Percentage of Participants With Overall Response (OR)', 'timeFrame': 'From the date of the first response until the primary analysis data cut-off date of 31 July 2018 (median duration of follow-up was 24.14 weeks)', 'description': 'Percentage of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) assessed by International Myeloma Working Group (IMWG) uniform response criteria. sCR: CR as defined plus normal FLC ratio \\& absence of clonal cells in bone marrow. CR: negative immunofixation on serum \\& urine; disappearance of any soft tissue plasmacytomas; \\<5% plasma cells in bone marrow; normal FLC ratio of 0.26-1.65. VGPR: serum \\& urine M-protein detectable by immunofixation; \\>=90% reduction in serum M-protein plus urine M-protein level \\<100 mg/24 h; \\>90% decrease in difference between involved \\& uninvolved FLC levels required. PR: \\>=50% reduction of serum M-protein \\& reduction in 24h urinary M protein by \\>=90%/\\<200 mg/24 h; if serum \\& urine M-protein unmeasurable:\\>=50% decrease in difference between involved \\& uninvolved FLC; if serum \\& urine M-protein not measurable:\\>=50% reduction in plasma cells required, in place of M-protein.'}], 'secondaryOutcomes': [{'measure': 'Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From first dose of study drug up to 30 days after the last dose of study drug administration (maximum duration of exposure: up to 112 weeks for Cohort 1 and 137 weeks for Cohort 2)', 'description': 'An AE was defined as any untoward medical occurrence in a participant or clinical investigation patient administered with a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TESAEs was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that develop, worsened or became serious during the on-treatment period (time from first dose of study drug up to 30 days after the last dose of study drug administration).'}, {'measure': 'Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From first dose of study drug up to 30 days after the last dose of study drug administration (maximum duration of exposure: up to 248 weeks)', 'description': 'An AE was defined as any untoward medical occurrence in a participant or clinical investigation patient administered with a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. TESAEs was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs are defined as AEs that develop, worsened or became serious during the on-treatment period (time from first dose of study drug up to 30 days after the last dose of study drug administration).'}, {'measure': 'Phase 1: Percentage of Participants With Overall Response (OR)', 'timeFrame': 'From the date of the first response until disease progression, or death due to any cause, whichever comes first (maximum duration of exposure: up to 112 weeks for Cohort 1 and 137 weeks for Cohort 2)', 'description': 'Percentage of participants with sCR, CR, VGPR, and PR assessed by IMWG uniform response criteria. sCR: CR as defined plus normal FLC ratio \\& absence of clonal cells in bone marrow. CR: negative immunofixation on serum \\& urine; disappearance of any soft tissue plasmacytomas; \\<5 percentage (%) plasma cells in bone marrow; normal FLC ratio of 0.26-1.65. VGPR: serum \\& urine M-protein detectable by immunofixation; \\>=90% reduction in serum M-protein plus urine M-protein level \\<100 mg/24 hour (h); \\>90% decrease in difference between involved \\& uninvolved FLC levels required. PR: \\>=50% reduction of serum M-protein \\& reduction in 24h urinary M protein by \\>=90%/\\<200 mg/24 h; if serum \\& urine M-protein unmeasurable:\\>=50% decrease in difference between involved \\& uninvolved FLC; if serum \\& urine M-protein not measurable:\\>=50% reduction in plasma cells required, in place of M-protein.'}, {'measure': 'Phase 1: Duration of Response (DOR)', 'timeFrame': 'From the date of the first response until disease progression, or death due to any cause, whichever comes first (maximum duration of exposure: up to 112 weeks for Cohort 1 and 137 weeks for Cohort 2)', 'description': 'DOR: time (in weeks) from date of first response to date of subsequent progressive disease (PD) or death, whichever happens earlier. In absence of confirmation of subsequent PD or death before cut-off date, DOR was censored at date of last valid assessment performed or date of initiation of new anticancer treatment, whichever was earlier. PD (IMWG criteria): increase (inc.) of \\>=25% from lowest response value in any one of following: serum M-component (absolute inc.\\>=0.5 g/dL) and/or; urine M-component (absolute inc.\\>=200 mg/24h) and/or, in participants without measurable serum \\& urine M-protein: difference between involved \\& uninvolved FLC levels (absolute inc. \\>10 mg/dL); in participants without measurable serum \\& urine M-protein and without measurable disease by FLC levels, bone marrow plasma cell % (absolute % \\>=10%); development of new bone lesions or soft tissue plasmacytomas/definite inc. in size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia.'}, {'measure': 'Phase 2: Percentage of Participants With Clinical Benefit (CB)', 'timeFrame': 'From date of first study treatment administration until first documented response, or death due to any cause, whichever comes first (maximum duration of exposure: up to 248 weeks)', 'description': 'CB defined as percentage of participants with sCR, CR, VGPR, PR or Minor/minimal response (MR) assessed by IMWG criteria. sCR: CR as defined plus normal FLC ratio \\& absence of clonal cells. CR: negative immunofixation on serum \\& urine; disappearance of any soft tissue plasmacytomas; \\<5% plasma cells in bone marrow; normal FLC ratio: 0.26-1.65. VGPR: serum \\& urine M-protein detectable by immunofixation; \\>=90% reduction in serum M-protein plus urine M-protein level \\<100 mg/24h; \\>90% decrease in difference between involved \\& uninvolved FLC levels required. PR: \\>=50% reduction of serum M-protein \\& reduction in 24h urinary M protein by \\>=90%/\\<200 mg/24 h; if serum \\& urine M-protein unmeasurable:\\>=50% decrease in difference between involved \\& uninvolved FLC; if serum \\& urine M-protein not measurable:\\>=50% reduction in plasma cells required. MR: \\>=25% but \\<=49% reduction of serum M protein and reduction in 24h urine M protein by 50-89%; 25-49% reduction in size of soft tissue plasmacytomas.'}, {'measure': 'Phase 2: Overall Survival (OS)', 'timeFrame': 'From date of first study treatment administration to the date of death due to any cause (maximum duration of exposure: up to 248 weeks)', 'description': 'Overall survival was defined as the time interval (in months) from the date of first study treatment administration to death due to any cause. In the absence of the confirmation of death before the cut-off date, OS was censored at the last date the participant was known to be alive or at the study cut-off date, whichever was earlier. Analysis was performed by Kaplan-Meier method.'}, {'measure': 'Phase 2: Progression Free Survival (PFS)', 'timeFrame': 'From date of first study treatment administration until disease progression or death due to any cause, whichever comes first (maximum duration of exposure: up to 248 weeks)', 'description': 'PFS was defined as the time interval (in months) from date of first study treatment administration until disease progression or death due to any cause, whichever comes first. In absence of PD or death, PFS was censored at date of last valid assessment performed before cut-off date or date of initiation of new anticancer treatment, whichever was earlier. PD (IMWG criteria): inc. of \\>=25% in any one of following: serum M-component absolute (abs.) inc. \\>=0.5 g/dL) and/or; urine M-component (abs. inc. \\>=200 mg/24h) and/or, in participants without measurable serum \\& urine M-protein, difference between involved \\& uninvolved FLC levels (abs. inc. \\>10 mg/dL); in participants without measurable serum \\& urine M-protein \\& without measurable disease by FLC levels: bone marrow plasma cell % (abs. % \\>=10%); definite development of new bone lesions or soft tissue plasmacytomas or definite inc. in size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia.'}, {'measure': 'Phase 2: Duration of Response (DOR)', 'timeFrame': 'From the date of first response until disease progression, or death due to any cause, whichever comes first (maximum duration of exposure: up to 248 weeks)', 'description': 'DOR was defined as time (in weeks) from date of first response to date of subsequent progressive disease (PD) or death, whichever happens earlier. In absence of confirmation of subsequent PD or death before cut-off date, DOR was censored at date of last valid assessment performed or date of initiation of new anticancer treatment, whichever was earlier. PD (IMWG criteria):inc. of \\>=25% from lowest response value in any one of following: serum M-component (absolute inc.\\>=0.5 g/dL) and/or; urine M-component (absolute inc.\\>=200 mg/24h) and/or, in participants without measurable serum \\& urine M-protein: difference between involved \\& uninvolved FLC levels (absolute inc.\\>10 mg/dL); in participants without measurable serum \\& urine M-protein and without measurable disease by FLC levels, bone marrow plasma cell % (absolute% \\>=10%); development of new bone lesions or soft tissue plasmacytomas/definite inc. in size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia.'}, {'measure': 'Phase 2: Time to Progression (TTP)', 'timeFrame': 'From date of first study treatment administration until disease progression, or death due to any cause, whichever comes first (maximum duration of exposure: up to 248 weeks)', 'description': 'TTP: time interval (in months) from date of first study treatment administration to date of first assessed disease progression. In absence of disease progression, TTP was censored at date of last valid assessment performed before cut-off date or date of initiation of new anticancer treatment, whichever was earlier. PD (IMWG criteria): inc. of \\>=25% from lowest response value in any one of following: serum M-component (absolute inc.\\>=0.5 g/dL) and/or; urine M-component (absolute inc.\\>=200 mg/24h) and/or, in participants without measurable serum \\& urine M-protein: difference between involved \\& uninvolved FLC levels (absolute inc.\\>10 mg/dL); in participants without measurable serum \\& urine M-protein and without measurable disease by FLC levels, bone marrow plasma cell % (absolute% \\>=10%); development of new bone lesions or soft tissue plasmacytomas/definite inc. in size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia.'}, {'measure': 'Phase 1: Plasma Concentration Observed at the End of Intravenous Infusion (Ceoi) of Isatuximab', 'timeFrame': 'End of infusion on Day 1 of Cycle 1', 'description': 'Ceoi is the plasma concentration observed at the end of intravenous infusion.'}, {'measure': 'Phase 1: Maximum Observed Concentration (Cmax) After First Infusion of Isatuximab', 'timeFrame': 'Cycle 1 Day 1 at 0 hour (pre-dose), mid-infusion (2 hours post-infusion), end of infusion (EOI) and EOI+4-hour, Day 2 (24 hour), Day 3 (48 hour), Day 4 (72 hour) and pre-dose on Day 8 (0 hour)', 'description': 'Cmax was defined as the maximum concentration observed after the first infusion calculated using the non-compartmental analysis.'}, {'measure': 'Phase 1: Time to Reach the Maximum Concentration (Tmax) After First Infusion of Isatuximab', 'timeFrame': 'Cycle 1 Day 1 at 0 hour (pre-dose), mid-infusion (2 hours post-infusion), EOI and EOI+4-hour, Day 2 (24 hour), Day 3 (48 hour), Day 4 (72 hour) and pre-dose on Day 8 (0 hour)', 'description': 'Tmax was defined as the time to reach Cmax, calculated using the non-compartmental analysis after the intravenous infusion.'}, {'measure': 'Phase 1: Area Under the Plasma Concentration Versus Curve Over the Dosing Interval (AUC1-week) After First Infusion of Isatuximab', 'timeFrame': 'Cycle 1 Day 1 at 0 hour (pre-dose), mid-infusion (2 hours post-infusion), EOI and EOI+4-hour, Day 2 (24 hour), Day 3 (48 hour), Day 4 (72 hour) and pre-dose on Day 8 (0 hour)', 'description': 'AUC was defined as area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval.'}, {'measure': 'Phase 1: Trough Plasma Concentrations (Ctrough) of Isatuximab', 'timeFrame': 'Pre-infusion on Cycle 1 Day 8 (C1 D8), C1 D15, C1 D22, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15, C5 D1, C5 D15, C6 D1, C6 D15, C7 D1, C7 D15, C8 D1, C8 D15, C9 D1, C9 D15, C10 D1, C10 D15, C11 D1', 'description': 'Ctrough was the plasma concentration observed just before treatment administration during repeated dosing.'}, {'measure': 'Phase 2: Maximum Observed Concentration (Cmax) After First Infusion of Isatuximab', 'timeFrame': 'Multiple timepoints from Cycle 1 to Cycle 10', 'description': 'Cmax was predicted using population pharmacokinetic model.'}, {'measure': 'Phase 2: Area Under the Plasma Concentration Versus Curve Over the Dosing Interval (AUC1-Week) After First Infusion of Isatuximab', 'timeFrame': 'Multiple timepoints from Cycle 1 to Cycle 10', 'description': 'AUC was predicted using population pharmacokinetic model.'}, {'measure': 'Phase 2: Trough Plasma Concentrations (Ctrough) of Isatuximab', 'timeFrame': 'Pre-infusion on C1 D8, C1 D15, C1 D22, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15, C5 D1, C5 D15, C6 D1, C6 D15, C7 D1, C7 D15, C8 D1, C8 D15, C9 D1, C9 D15, C10 D1, C10 D15', 'description': 'Ctrough was the plasma concentration observed just before treatment administration during repeated dosing.'}, {'measure': 'Phase 1 and 2: CD38 Receptor Density at Baseline', 'timeFrame': 'At Baseline (Day 1)', 'description': "CD38 receptor density assessed from bone marrow aspirates for responder and non-responders' participants was reported."}, {'measure': 'Phase 1: Number of Participants With Anti-drug Antibodies (ADA) Response Against Isatuximab', 'timeFrame': 'From first dose of study drug up to 30 days after last study drug administration (maximum duration of exposure: up to 112 weeks for Cohort 1, and 137 weeks for Cohort 2)', 'description': 'ADA were categorized as: treatment induced, and treatment boosted response. Treatment-induced ADA: ADA that developed at any time during the ADA on-study observation period in participants without preexisting ADA (ADA that was present in samples drawn during the ADA pretreatment period). Treatment boosted ADA: Preexisting ADA with an increase in titer value between pretreatment \\& posttreatment samples of at least two titer steps, during the ADA on-study observation period.'}, {'measure': 'Phase 2: Number of Participants With Anti-drug Antibodies (ADA) Response Against Isatuximab', 'timeFrame': 'From first dose of study drug up to 30 days after last study drug administration (maximum duration of exposure: up to 248 weeks)', 'description': 'ADA were categorized as: treatment induced, and treatment boosted response. Treatment-induced ADA: ADA that developed at any time during the ADA on-study observation period in participants without preexisting ADA (ADA that was present in samples drawn during the ADA pretreatment period). Treatment boosted ADA: Preexisting ADA with an increase in titer value between pretreatment \\& posttreatment samples of at least two titer steps, during the ADA on-study observation period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anti-CD38 monoclonal antibody'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '36433829', 'type': 'RESULT', 'citation': 'Sunami K, Fuchida SI, Suzuki K, Ri M, Matsumoto M, Shimazaki C, Asaoku H, Shibayama H, Ishizawa K, Takamatsu H, Ikeda T, Maruyama D, Imada K, Uchiyama M, Kiguchi T, Iyama S, Murakami H, Onishi R, Tada K, Iida S. Anti-CD38 antibody isatuximab monotherapy for Japanese individuals with relapsed/refractory multiple myeloma: An update of the phase 1/2 ISLANDs study. Hematol Oncol. 2023 Aug;41(3):442-452. doi: 10.1002/hon.3105. Epub 2022 Dec 15.'}, {'pmid': '32975869', 'type': 'RESULT', 'citation': 'Sunami K, Suzuki K, Ri M, Matsumoto M, Shimazaki C, Asaoku H, Shibayama H, Ishizawa K, Takamatsu H, Ikeda T, Maruyama D, Kaneko H, Uchiyama M, Kiguchi T, Iyama S, Murakami H, Takahashi K, Tada K, Mace S, Guillemin-Paveau H, Iida S. Isatuximab monotherapy in relapsed/refractory multiple myeloma: A Japanese, multicenter, phase 1/2, safety and efficacy study. Cancer Sci. 2020 Dec;111(12):4526-4539. doi: 10.1111/cas.14657. Epub 2020 Oct 15.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objectives:\n\n* Phase I: To evaluate safety and tolerability of isatuximab in Japanese participants with relapsed and refractory multiple myeloma.\n* Phase II: To evaluate efficacy of isatuximab at recommended dose and to further evaluate the overall response rate (ORR) of isatuximab in Japanese participants with relapsed and refractory multiple myeloma.\n\nSecondary Objectives:\n\n* To evaluate the safety including immunogenicity of isatuximab. The severity, frequency and incidence of all adverse events were assessed.\n* To evaluate the pharmacokinetic (PK) profile of isatuximab in the proposed dosing schedule.\n* To assess the efficacy using International Myeloma Working Group (IMWG) uniform response criteria.\n* To assess the relationship between Baseline cluster of differentiation 38 (CD38) receptor density on multiple myeloma cells and efficacy.', 'detailedDescription': 'The study duration for an individual participant included a screening period for inclusion of up to 21 days, the treatment period consisting of 28-day cycles and a follow-up period. Treatment with isatuximab might continue until disease progression, unacceptable adverse event, or other reason for discontinuation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Males or females, age 20 years or older.\n* Participants had a known diagnosis of symptomatic multiple myeloma.\n* Participants had received at least 3 prior lines of therapies OR participants whose disease was double refractory to an Immunomodulatory Drug (IMiD) and a Proteasome Inhibitor (PI).\n* Participants had been responsive (i.e., minimal response \\[MR\\] or better) to at least one prior line of therapy.\n* Refractory to the most recently received IMiD or PI included therapy.\n* Participants with measurable disease defined as at least one of the following:\n* Immunoglobulin G (IgG) Type: Serum M-protein \\>=1 gram per deciliter (g/dL) (\\>=10 g/L);\n* Immunoglobulin A (IgA) and D Type: Serum M-protein, quantification should be performed;\n* Urine M-protein ≥200 mg/24 hours.\n* Participants with a Eastern Cooperative Oncology Group (ECOG) performance status \\<=2.\n\nExclusion criteria:\n\n* Participants treated with any anti-CD38 agent.\n* Diagnosed or treated for another malignancy within 5 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low-risk prostate cancer after curative therapy.\n* Prior anticancer therapy (chemotherapy, targeted agents, immunotherapy) within 21 days prior to the first drug infusion unless otherwise specified below:\n* Alkylating agents (e.g., Melphalan) within 28 days prior to the first dose of study treatment.\n* Steroids treatment (e.g., prednisone greater than (\\>)10 mg/day orally or equivalent except patients being treated for adrenal insufficiency/replacement therapy or treated for inhalation corticosteroids) within 14 days prior to the first dose of study treatment.\n* Participated in another clinical trial within 30 days prior to the first dose of study treatment.\n* Participants treated with systemic radiation therapy within 4 weeks prior to the first dose of study treatment OR Localized radiation therapy within 1 week prior to the first dose of study treatment.\n* Major surgical procedure within 4 weeks prior to the first dose of study treatment.\n* Any toxicity Grade \\>=2 (excluding alopecia, neutropenia or neuropathy) related to any prior anti-cancer therapy according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.\n* Neuropathy Grade \\>=3 or painful peripheral neuropathy Grade \\>=2.\n* History of significant cardiovascular disease unless the disease within the past 6 months was well-controlled.\n* Previously received an allogenic stem cell transplant.\n* Diagnosed Crow-Fukase (POEMS) syndrome OR plasma cell leukemia.\n* Participants with known or suspected amyloidosis.\n* Participants with Waldenstrom's macroglobulinemia OR Multiple myeloma IgM subtype.\n* Participants with active infection.\n* Known human immunodeficiency virus (HIV) or active hepatitis B or C viral infection.\n* Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation.\n* Any severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results.\n* Hypersensitivity or history of intolerance to boron or mannitol, sucrose, histidine (as base and hydrochloride salt) and polysorbate 80 or any of the components of study therapy that are not amenable to pre-medication with steroids and H2 blockers or would prohibit further treatment with these agents.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT02812706', 'acronym': 'Islands', 'briefTitle': 'Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase I/II Study of Isatuximab (Anti-CD38 mAb) Administered as a Single Agent in Japanese Patients With Relapsed and Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'TED14095'}, 'secondaryIdInfos': [{'id': 'U1111-1175-0679', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1, Cohort 1: Isatuximab 10 mg/kg', 'description': 'Participants received Isatuximab 10 milligram per kilogram (mg/kg) intravenous (IV) infusion once every week (QW) for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then every 2 weeks (Q2W) (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable adverse events, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).', 'interventionNames': ['Drug: Isatuximab SAR650984']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1, Cohort 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable adverse events, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).', 'interventionNames': ['Drug: Isatuximab SAR650984']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2: Isatuximab 20 mg/kg', 'description': 'Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable adverse events, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).', 'interventionNames': ['Drug: Isatuximab SAR650984']}], 'interventions': [{'name': 'Isatuximab SAR650984', 'type': 'DRUG', 'otherNames': ['Sarclisa'], 'description': 'Pharmaceutical form: solution Route of administration: intravenous', 'armGroupLabels': ['Phase 1, Cohort 1: Isatuximab 10 mg/kg', 'Phase 1, Cohort 2: Isatuximab 20 mg/kg', 'Phase 2: Isatuximab 20 mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '467-8602', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Investigational Site Number :392001', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '377-0280', 'city': 'Shibukawa-shi', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Investigational Site Number :392005'}, {'zip': '730-8619', 'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Investigational Site Number :392010', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '920-8641', 'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Investigational Site Number :392015', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '603-8151', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Investigational Site Number :392016', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '392-8510', 'city': 'Suwa-shi', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Investigational Site Number :392008'}, {'zip': '701-1192', 'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Investigational Site Number :392003', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '543-8555', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Investigational Site Number :392009', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '565-0871', 'city': 'Suita-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Investigational Site Number :392013'}, {'zip': '411-8777', 'city': 'Sunto-gun', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Investigational Site Number :392017'}, {'zip': '104-0045', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Investigational Site Number :392012'}, {'zip': '150-8935', 'city': 'Shibuya-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Investigational Site Number :392002'}, {'zip': '990-9585', 'city': 'Yamagata', 'country': 'Japan', 'facility': 'Investigational Site Number :392011', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case 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