Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:46 AM
Study NCT ID:
NCT00833833
Status:
COMPLETED
Last Update Posted:
2016-04-27
First Post:
2009-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
MTD, Safety, and Efficacy of Pomalidomide (CC-4047) Alone or With Low-dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C467566', 'term': 'pomalidomide'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C004180', 'term': 'dexamethasone 21-phosphate'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialdisclosure@celgene.com', 'phone': '1-888-260-1599', 'title': 'Associate Director, Clinical Trials Disclosure', 'organization': 'Celgene Corporation'}, 'certainAgreement': {'otherDetails': '* Multicenter publication must include input from investigators and Celgene, and has priority over subset (single center) publication, for 1 year after study completion.\n* Investigators have publication right after multicenter publication is complete (or 1 year after study completion), whichever is first. Celgene has 45 days to review and comment on draft manuscript/presentation, and may ask for an additional delay (not to exceed 90 days total) to address intellectual property issues.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Data cut-off 01 April 2011 Phase 1: up to 126 weeks Phase 2: up to 70 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1: 2 mg Pomalidomide', 'description': 'Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Phase 1: 3 mg Pomalidomide', 'description': 'Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Phase 1: 4 mg Pomalidomide', 'description': 'Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.', 'otherNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'Phase 1: 5 mg Pomalidomide', 'description': 'Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Phase 2: Pomalidomide + Dexamethasone', 'description': 'Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.', 'otherNumAtRisk': 112, 'otherNumAffected': 112, 'seriousNumAtRisk': 112, 'seriousNumAffected': 69}, {'id': 'EG005', 'title': 'Phase 2: Pomalidomide (Pom Only)', 'description': 'Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.\n\nData are reported during the time when participants were on pomalidomide alone, before dexamethasone was added.', 'otherNumAtRisk': 107, 'otherNumAffected': 105, 'seriousNumAtRisk': 107, 'seriousNumAffected': 50}, {'id': 'EG006', 'title': 'Phase 2: Pomalidomide (Pom + Dex Only)', 'description': 'Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.\n\nData are reported during the time after PD when participants were on both pomalidomide and dexamethasone.', 'otherNumAtRisk': 61, 'otherNumAffected': 57, 'seriousNumAtRisk': 61, 'seriousNumAffected': 29}, {'id': 'EG007', 'title': 'Phase 2: Pomalidomide (Overall)', 'description': 'Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.\n\nData are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone.', 'otherNumAtRisk': 107, 'otherNumAffected': 106, 'seriousNumAtRisk': 107, 'seriousNumAffected': 72}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 62}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 46}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 11}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 31}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 15}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 18}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 22}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Feeling jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Catheter site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 52}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 53}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 17}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 55}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 43}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 36}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 11}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 41}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 24}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 25}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 38}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 29}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 11}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 112, 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'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Blood culture positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1: Participants With Dose-Limiting Toxicities (DLT) in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: 2 mg Pomalidomide', 'description': 'Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}, {'id': 'OG001', 'title': 'Phase 1: 3 mg Pomalidomide', 'description': 'Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}, {'id': 'OG002', 'title': 'Phase 1: 4 mg Pomalidomide', 'description': 'Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}, {'id': 'OG003', 'title': 'Phase 1: 5 mg Pomalidomide', 'description': 'Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 28 (Cycle 1)', 'description': 'The maximum tolerated dose was defined as the highest dose level at which no more than 1 of 6 participants experiences a DLT within the first 28-day cycle.\n\nDLTs were defined as:\n\n* Grade 4 neutropenia or thrombocytopenia\n* Febrile neutropenia\n* Grade 3 or 4 nausea, vomiting or diarrhea despite optimal symptomatic treatment\n* Serum transaminase \\> 20 \\* upper limit of normal (ULN)\n* Serum transaminase \\> 5 \\* ULN for \\>= 7 days\n* Delay of the start of cycle 2 by \\>7 days due to pomalidomide-related adverse event', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'PRIMARY', 'title': 'Phase 2: Kaplan-Meier Estimates of Progression-free Survival (PFS) as of the 01 April 2011 Cut-off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Pomalidomide + Dexamethasone', 'description': 'Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Phase 2: Pomalidomide', 'description': '4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': '21.1'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '16.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.54', 'ciUpperLimit': '0.99', 'groupDescription': 'With a 12-month accrual period and 12-month follow-up after the study closed to accrual, assuming a 10% drop out rate, 96 participants in each treatment arm would have had 85% power to detect a hazard rate ratio of 1.67 using a one-sided log rank test with an overall significance level of 0.025 adjusted for one interim analysis) and a significance level of 0.0245 for the final analysis.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 67 weeks', 'description': 'Progression free survival (PFS) is the time from randomization to the first documentation of disease progression or death from any cause during study, whichever occurs earlier. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).\n\nFor the primary PFS analysis, participants who withdrew for any reason or received another antimyeloma therapy (except adding dexamethasone to the Phase 2: Pomalidomide arm) without documented PD (as determined by the IRAC review) were censored on the date of their last adequate response assessment, prior to receiving any other anti-myeloma therapy. Subjects who were still active at the time of the data cut-off date without PD (as determined by the IRAC) were censored on the date of their last adequate response assessment.\n\nData collection is ongoing and future data results will be included as available.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population.\n\nData collection is ongoing and future data results will be included as available.'}, {'type': 'SECONDARY', 'title': 'Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Single-Agent Pomalidomide as of the 01 April 2011 Cut-off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: 2 mg Pomalidomide', 'description': 'Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}, {'id': 'OG001', 'title': 'Phase 1: 3 mg Pomalidomide', 'description': 'Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}, {'id': 'OG002', 'title': 'Phase 1: 4 mg Pomalidomide', 'description': 'Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}, {'id': 'OG003', 'title': 'Phase 1: 5 mg Pomalidomide', 'description': 'Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}], 'classes': [{'title': '1 or more (1+) AE', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}]}]}, {'title': '1+ AE related to pomalidomide', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '85.7', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}]}]}, {'title': '1+ severity grade 3-4 AE', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}, {'value': '78.6', 'groupId': 'OG002'}, {'value': '80.0', 'groupId': 'OG003'}]}]}, {'title': '1+ severity grade 3-4 AE related to pomalidomide', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}, {'value': '70.0', 'groupId': 'OG003'}]}]}, {'title': '1+ serious AE (SAE)', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}, {'value': '30.0', 'groupId': 'OG003'}]}]}, {'title': '1+ SAE related to pomalidomide', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '7.1', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}]}]}, {'title': '1+ AE leading to discontinuation of pomalidomide', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '21.4', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': '1+AE-dose reduction/interruption of pomalidomide', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}, {'value': '80.0', 'groupId': 'OG003'}]}]}, {'title': '1+related AE-reduction/interruption of pomalidomid', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}, {'value': '70.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to week 104', 'description': 'Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.\n\nData collection is ongoing and future data results will be included as available.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population.\n\nData collection is ongoing and future data results will be included as available.'}, {'type': 'SECONDARY', 'title': 'Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Pomalidomide and Dexamethasone as of the 01 April 2011 Cut-off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: 2 mg Pomalidomide', 'description': 'Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}, {'id': 'OG001', 'title': 'Phase 1: 3 mg Pomalidomide', 'description': 'Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}, {'id': 'OG002', 'title': 'Phase 1: 4 mg Pomalidomide', 'description': 'Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}, {'id': 'OG003', 'title': 'Phase 1: 5 mg Pomalidomide', 'description': 'Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}], 'classes': [{'title': '1 or more (1+) AE', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '90.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}]}]}, {'title': '1+ AE related to pomalidomide', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '80.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}]}]}, {'title': '1+ AE related to dexamethasone', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '70.0', 'groupId': 'OG002'}, {'value': '85.7', 'groupId': 'OG003'}]}]}, {'title': '1+ severity grade 3-4 AE', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '70.0', 'groupId': 'OG002'}, {'value': '57.1', 'groupId': 'OG003'}]}]}, {'title': '1+ severity grade 3-4 AE related to pomalidomide', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}, {'value': '42.9', 'groupId': 'OG003'}]}]}, {'title': '1+ severity grade 3-4 AE related to dexamethasone', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': '1+ serious AE (SAE)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '40.0', 'groupId': 'OG002'}, {'value': '28.6', 'groupId': 'OG003'}]}]}, {'title': '1+ SAE related to pomalidomide', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': '1+ SAE related to dexamethasone', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '10.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': '1+ AE leading to discontinuation of pomalidomide', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': '1+ AE -- discontinuation of dexamethasone', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': '1+AE -dose reduction/interruption of pomalidomide', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '40.0', 'groupId': 'OG002'}, {'value': '71.4', 'groupId': 'OG003'}]}]}, {'title': '1+ AE-dose reduction/interruption of dexamethasone', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '60.0', 'groupId': 'OG002'}, {'value': '71.4', 'groupId': 'OG003'}]}]}, {'title': '1+related AE-reduction/interruption of pomalidomid', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}, {'value': '57.1', 'groupId': 'OG003'}]}]}, {'title': '1+related AE-reduction/interruption of dexamethaso', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}, {'value': '42.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to week 126', 'description': 'TEAEs that occurred during Phase 1 after dexamethasone was added to pomalidomide treatment.\n\nRelation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.\n\nData collection is ongoing and future data results will be included as available.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population.\n\nData collection is ongoing and future data results will be included as available.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as of the 01 April 2011 Cut-off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '107', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Pomalidomide + Dexamethasone', 'description': 'Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Phase 2: Pomalidomide (Pom Only)', 'description': 'Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.\n\nData are reported during the time when participants were on pomalidomide alone, before dexamethasone was added.'}, {'id': 'OG002', 'title': 'Phase 2: Pomalidomide (Pom + Dex Only)', 'description': 'Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.\n\nData are reported during the time after PD when participants were on both pomalidomide and dexamethasone.'}, {'id': 'OG003', 'title': 'Phase 2: Pomalidomide (Overall)', 'description': 'Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.\n\nData are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone.'}], 'classes': [{'title': '1 or more (1+) AE', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '99.1', 'groupId': 'OG001'}, {'value': '93.4', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}]}]}, {'title': '1+ AE related to pomalidomide', 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000'}, {'value': '87.9', 'groupId': 'OG001'}, {'value': '68.9', 'groupId': 'OG002'}, {'value': '88.8', 'groupId': 'OG003'}]}]}, {'title': '1+ severity grade 3-4 AE', 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000'}, {'value': '84.1', 'groupId': 'OG001'}, {'value': '70.5', 'groupId': 'OG002'}, {'value': '89.7', 'groupId': 'OG003'}]}]}, {'title': '1+ severity grade 3-4 AE related to pomalidomide', 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}, {'value': '58.9', 'groupId': 'OG001'}, {'value': '44.3', 'groupId': 'OG002'}, {'value': '67.3', 'groupId': 'OG003'}]}]}, {'title': '1+ serious AE (SAE)', 'categories': [{'measurements': [{'value': '61.6', 'groupId': 'OG000'}, {'value': '46.7', 'groupId': 'OG001'}, {'value': '47.5', 'groupId': 'OG002'}, {'value': '67.3', 'groupId': 'OG003'}]}]}, {'title': '1+ SAE related to pomalidomide', 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}, {'value': '19.7', 'groupId': 'OG002'}, {'value': '20.6', 'groupId': 'OG003'}]}]}, {'title': '1+ AE leading to discontinuation of pomalidomide', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}, {'value': '3.3', 'groupId': 'OG002'}, {'value': '12.1', 'groupId': 'OG003'}]}]}, {'title': '1+related AE --discontinuation of pomalidomide', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '3.7', 'groupId': 'OG003'}]}]}, {'title': '1+AE - reduction of pomalidomide', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000'}, {'value': '25.2', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}, {'value': '29.9', 'groupId': 'OG003'}]}]}, {'title': '1+ AE - interruption of pomalidomide', 'categories': [{'measurements': [{'value': '63.4', 'groupId': 'OG000'}, {'value': '47.7', 'groupId': 'OG001'}, {'value': '36.1', 'groupId': 'OG002'}, {'value': '58.9', 'groupId': 'OG003'}]}]}, {'title': '1+ related AE - interruption of pomalidomide', 'categories': [{'measurements': [{'value': '27.7', 'groupId': 'OG000'}, {'value': '24.3', 'groupId': 'OG001'}, {'value': '21.3', 'groupId': 'OG002'}, {'value': '32.7', 'groupId': 'OG003'}]}]}, {'title': '1+related AE - reduction of pomalidomide', 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000'}, {'value': '20.6', 'groupId': 'OG001'}, {'value': '8.2', 'groupId': 'OG002'}, {'value': '24.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to week 70', 'description': 'Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.\n\nData collection is ongoing and future data results will be included as available.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population.\n\nData collection is ongoing and future data results will be included as available.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Summary of Best Myeloma Response As Assessed by Independent Response Adjudication Committee (IRAC) Using European Group for Blood and Bone Marrow Transplant (EBMT) Criteria as of the 01 April 2011 Cut-off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Pomalidomide + Dexamethasone', 'description': 'Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Phase 2: Pomalidomide', 'description': '4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.'}], 'classes': [{'title': 'Complete response (CR)', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Partial response (PR)', 'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'Minimal response (MR)', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000'}, {'value': '15.7', 'groupId': 'OG001'}]}]}, {'title': 'Stable disease (SD)', 'categories': [{'measurements': [{'value': '35.4', 'groupId': 'OG000'}, {'value': '46.3', 'groupId': 'OG001'}]}]}, {'title': 'Progressive disease (PD)', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '15.7', 'groupId': 'OG001'}]}]}, {'title': 'Not evaluable', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '13.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 70 weeks', 'description': 'IRAC used EBMT criteria to assess myeloma response:\n\n* Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of lytic bone lesions, plus other factors)\n* Partial Response (PR)-not all CR criteria, plus \\>=50% reduction in serum monoclonal paraprotein plus others\n* Minimal Response (MR)- 25-49% reduction in serum monoclonal paraprotein plus others\n* Stable Disease (SD)- not MR or progressive disease (PD)\n* Progressive Disease (PD)- reappearance of monoclonal paraprotein, lytic bone lesions, other\n* Not Evaluable (NE).\n\nData collection is ongoing and future data results will be included as available.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population.\n\nData collection is ongoing and future data results will be included as available.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Kaplan-Meier Estimates of Duration of Response as of the 01 April 2011 Cut-off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Pomalidomide + Dexamethasone', 'description': 'Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Phase 2: Pomalidomide', 'description': '4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000', 'lowerLimit': '22.1', 'upperLimit': '39.9'}, {'value': 'NA', 'comment': 'Not estimable since 9 or 10 responders were censored. The median was not reached at the time of the data cut-off.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.25', 'ciLowerLimit': '0.84', 'ciUpperLimit': '46.66', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 70 weeks', 'description': 'Duration of myeloma response is defined as the time from when the response criteria are first met for partial response (PR) or better, until the first date the response criteria are met for progressive disease (PD) or until the participant dies from any cause, whichever occurs first. Duration of response for participants last known to be alive with no progression after a complete response (CR) or PR was censored at the date of last adequate response assessment. Participants with confirmed responses that occur after receiving any other anti-myeloma therapy (except for adding dexamethasone to the pomalidomide treatment arm), including radiation therapy initiated after baseline, was censored at the last adequate assessment prior to the initiation of such treatment.\n\nResponse was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described in the previous outcome.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Responders (participants with a complete response or partial response) from the ITT population.\n\nData collection is ongoing and future data results will be included as available.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Time to Response as of the 01 April 2011 Cut-off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Pomalidomide + Dexamethasone', 'description': 'Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Phase 2: Pomalidomide', 'description': '4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '45.1'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '49.6'}]}]}], 'analyses': [{'pValue': '0.070', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 70 weeks', 'description': 'Time to myeloma response is defined as the time from randomization to the time the response criteria for complete response (CR) or partial response (PR) are first met.\n\nResponse was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described previously.\n\nData collection is ongoing and future data results will be included as available.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Responders (participants achieving CR or PR) from ITT population.\n\nData collection is ongoing and future data results will be included as available.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Kaplan-Meier Estimates of Overall Survival as of the 01 April 2011 Cut-off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Pomalidomide + Dexamethasone', 'description': 'Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Phase 2: Pomalidomide', 'description': '4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.6', 'comment': 'Not estimable due to 69 out of 113 patients were still alive at data cutoff date', 'groupId': 'OG000', 'lowerLimit': '53.6', 'upperLimit': 'NA'}, {'value': '59.3', 'comment': 'Not estimable due to 61 out of 108 patients were still alive at data cutoff date', 'groupId': 'OG001', 'lowerLimit': '41.6', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.29', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 70 weeks', 'description': 'Overall survival was defined as the time between randomization and death. Participants who die, regardless of the cause of the death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the subject was known to be alive, or clinical cut-off date if it was earlier.\n\nData collection is ongoing and future data results will be included as available.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.\n\nData collection is ongoing and future data results will be included as available.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Percentage of Participants With Progression-Free Survival (PFS) Events as of the 01 April 2011 Cut-off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Pomalidomide + Dexamethasone', 'description': 'Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Phase 2: Pomalidomide', 'description': '4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.1', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 67 weeks', 'description': 'Percentage of participants with the progression-free survival events: disease progression and death. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).\n\nData collection is ongoing and future data results will be included as available.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population.\n\nData collection is ongoing and future data results will be included as available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1: 2 mg Pomalidomide', 'description': 'Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}, {'id': 'FG001', 'title': 'Phase 1: 3 mg Pomalidomide', 'description': 'Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}, {'id': 'FG002', 'title': 'Phase 1: 4 mg Pomalidomide', 'description': 'Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}, {'id': 'FG003', 'title': 'Phase 1: 5 mg Pomalidomide', 'description': 'Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}, {'id': 'FG004', 'title': 'Phase 2: Pomalidomide + Dexamethasone', 'description': 'Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.'}, {'id': 'FG005', 'title': 'Phase 2: Pomalidomide', 'description': '4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.'}], 'periods': [{'title': 'Phase 1 (as of 01 April 2011)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Confirmed progressive disease', 'groupId': 'FG000', 'numSubjects': '2'}, {'comment': 'Confirmed progressive disease', 'groupId': 'FG001', 'numSubjects': '3'}, {'comment': 'Confirmed progressive disease', 'groupId': 'FG002', 'numSubjects': '5'}, {'comment': 'Confirmed progressive disease', 'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Still active in study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Disease progression - unconfirmed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Phase 2 (as of 01 April 2011)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '113'}, {'groupId': 'FG005', 'numSubjects': '108'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '112'}, {'groupId': 'FG005', 'numSubjects': '107'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Confirmed progressive disease', 'groupId': 'FG004', 'numSubjects': '58'}, {'comment': 'Confirmed progressive disease', 'groupId': 'FG005', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '55'}, {'groupId': 'FG005', 'numSubjects': '61'}]}], 'dropWithdraws': [{'type': 'Still active in study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '23'}, {'groupId': 'FG005', 'numSubjects': '22'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '13'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'Disease progression - unconfirmed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Phase 2: Participants were stratified by age (≤ 75 vs. \\> 75), prior number of treatments (2 vs. \\> 2), and prior thalidomide exposure (yes vs. no).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '113', 'groupId': 'BG004'}, {'value': '108', 'groupId': 'BG005'}, {'value': '259', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1: 2 mg Pomalidomide', 'description': 'Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}, {'id': 'BG001', 'title': 'Phase 1: 3 mg Pomalidomide', 'description': 'Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}, {'id': 'BG002', 'title': 'Phase 1: 4 mg Pomalidomide', 'description': 'Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}, {'id': 'BG003', 'title': 'Phase 1: 5 mg Pomalidomide', 'description': 'Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.'}, {'id': 'BG004', 'title': 'Phase 2: Pomalidomide + Dexamethasone', 'description': 'Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.'}, {'id': 'BG005', 'title': 'Phase 2: Pomalidomide', 'description': '4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.7', 'spread': '6.83', 'groupId': 'BG000'}, {'value': '70.4', 'spread': '6.63', 'groupId': 'BG001'}, {'value': '67.5', 'spread': '8.98', 'groupId': 'BG002'}, {'value': '61.3', 'spread': '14.06', 'groupId': 'BG003'}, {'value': '64.4', 'spread': '9.24', 'groupId': 'BG004'}, {'value': '62.9', 'spread': '10.35', 'groupId': 'BG005'}, {'value': '64.1', 'spread': '9.86', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<=75 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '99', 'groupId': 'BG004'}, {'value': '95', 'groupId': 'BG005'}, {'value': '226', 'groupId': 'BG006'}]}]}, {'title': '>75 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '33', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '51', 'groupId': 'BG005'}, {'value': '122', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}, {'value': '137', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}, {'value': '86', 'groupId': 'BG005'}, {'value': '213', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Electrocardiogram Findings', 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}, {'value': '110', 'groupId': 'BG006'}]}]}, {'title': 'Abnormal, not clinically significant', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}, {'value': '59', 'groupId': 'BG005'}, {'value': '140', 'groupId': 'BG006'}]}]}, {'title': 'Abnormal, clinically significant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Eastern Cooperative Oncology Group Performance Status', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '62', 'groupId': 'BG006'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}, {'value': '71', 'groupId': 'BG005'}, {'value': '163', 'groupId': 'BG006'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'description': 'The ECOG scale is as follows:\n\nGrade 0: Fully active, able to carry on all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair \\> 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair.', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Multiple Myeloma Stage', 'classes': [{'title': 'Stage I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}]}]}, {'title': 'Stage II', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}, {'value': '64', 'groupId': 'BG006'}]}]}, {'title': 'Stage III', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}, {'value': '71', 'groupId': 'BG005'}, {'value': '172', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'description': 'Multiple myeloma has three stages, which are known as stage I, stage II and stage III. Staging in myeloma is done on the basis of the value of serum albumin and beta-2 microglobulin level. Stage I has the best prognosis and stage III the worst prognosis.', 'unitOfMeasure': 'participants'}, {'title': 'Prior Anti-Myeloma Therapies', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '113', 'groupId': 'BG004'}, {'value': '108', 'groupId': 'BG005'}, {'value': '259', 'groupId': 'BG006'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior Thalidomide Exposure', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}, {'value': '72', 'groupId': 'BG005'}, {'value': '178', 'groupId': 'BG006'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '36', 'groupId': 'BG005'}, {'value': '81', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior Stem Cell Transplant', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}, {'value': '82', 'groupId': 'BG005'}, {'value': '191', 'groupId': 'BG006'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '68', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intent to treat population from both phases'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 259}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-25', 'studyFirstSubmitDate': '2009-01-30', 'resultsFirstSubmitDate': '2013-03-08', 'studyFirstSubmitQcDate': '2009-01-30', 'lastUpdatePostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-08', 'studyFirstPostDateStruct': {'date': '2009-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Participants With Dose-Limiting Toxicities (DLT) in Cycle 1', 'timeFrame': 'Up to Day 28 (Cycle 1)', 'description': 'The maximum tolerated dose was defined as the highest dose level at which no more than 1 of 6 participants experiences a DLT within the first 28-day cycle.\n\nDLTs were defined as:\n\n* Grade 4 neutropenia or thrombocytopenia\n* Febrile neutropenia\n* Grade 3 or 4 nausea, vomiting or diarrhea despite optimal symptomatic treatment\n* Serum transaminase \\> 20 \\* upper limit of normal (ULN)\n* Serum transaminase \\> 5 \\* ULN for \\>= 7 days\n* Delay of the start of cycle 2 by \\>7 days due to pomalidomide-related adverse event'}, {'measure': 'Phase 2: Kaplan-Meier Estimates of Progression-free Survival (PFS) as of the 01 April 2011 Cut-off', 'timeFrame': 'up to 67 weeks', 'description': 'Progression free survival (PFS) is the time from randomization to the first documentation of disease progression or death from any cause during study, whichever occurs earlier. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).\n\nFor the primary PFS analysis, participants who withdrew for any reason or received another antimyeloma therapy (except adding dexamethasone to the Phase 2: Pomalidomide arm) without documented PD (as determined by the IRAC review) were censored on the date of their last adequate response assessment, prior to receiving any other anti-myeloma therapy. Subjects who were still active at the time of the data cut-off date without PD (as determined by the IRAC) were censored on the date of their last adequate response assessment.\n\nData collection is ongoing and future data results will be included as available.'}, {'measure': 'Phase 2: Percentage of Participants With Progression-Free Survival (PFS) Events as of the 01 April 2011 Cut-off', 'timeFrame': 'up to 67 weeks', 'description': 'Percentage of participants with the progression-free survival events: disease progression and death. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).\n\nData collection is ongoing and future data results will be included as available.'}], 'secondaryOutcomes': [{'measure': 'Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Single-Agent Pomalidomide as of the 01 April 2011 Cut-off', 'timeFrame': 'Up to week 104', 'description': 'Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.\n\nData collection is ongoing and future data results will be included as available.'}, {'measure': 'Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Pomalidomide and Dexamethasone as of the 01 April 2011 Cut-off', 'timeFrame': 'Up to week 126', 'description': 'TEAEs that occurred during Phase 1 after dexamethasone was added to pomalidomide treatment.\n\nRelation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.\n\nData collection is ongoing and future data results will be included as available.'}, {'measure': 'Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as of the 01 April 2011 Cut-off', 'timeFrame': 'Up to week 70', 'description': 'Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.\n\nData collection is ongoing and future data results will be included as available.'}, {'measure': 'Phase 2: Summary of Best Myeloma Response As Assessed by Independent Response Adjudication Committee (IRAC) Using European Group for Blood and Bone Marrow Transplant (EBMT) Criteria as of the 01 April 2011 Cut-off', 'timeFrame': 'up to 70 weeks', 'description': 'IRAC used EBMT criteria to assess myeloma response:\n\n* Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of lytic bone lesions, plus other factors)\n* Partial Response (PR)-not all CR criteria, plus \\>=50% reduction in serum monoclonal paraprotein plus others\n* Minimal Response (MR)- 25-49% reduction in serum monoclonal paraprotein plus others\n* Stable Disease (SD)- not MR or progressive disease (PD)\n* Progressive Disease (PD)- reappearance of monoclonal paraprotein, lytic bone lesions, other\n* Not Evaluable (NE).\n\nData collection is ongoing and future data results will be included as available.'}, {'measure': 'Phase 2: Kaplan-Meier Estimates of Duration of Response as of the 01 April 2011 Cut-off', 'timeFrame': 'up to 70 weeks', 'description': 'Duration of myeloma response is defined as the time from when the response criteria are first met for partial response (PR) or better, until the first date the response criteria are met for progressive disease (PD) or until the participant dies from any cause, whichever occurs first. Duration of response for participants last known to be alive with no progression after a complete response (CR) or PR was censored at the date of last adequate response assessment. Participants with confirmed responses that occur after receiving any other anti-myeloma therapy (except for adding dexamethasone to the pomalidomide treatment arm), including radiation therapy initiated after baseline, was censored at the last adequate assessment prior to the initiation of such treatment.\n\nResponse was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described in the previous outcome.'}, {'measure': 'Phase 2: Time to Response as of the 01 April 2011 Cut-off', 'timeFrame': 'up to 70 weeks', 'description': 'Time to myeloma response is defined as the time from randomization to the time the response criteria for complete response (CR) or partial response (PR) are first met.\n\nResponse was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described previously.\n\nData collection is ongoing and future data results will be included as available.'}, {'measure': 'Phase 2: Kaplan-Meier Estimates of Overall Survival as of the 01 April 2011 Cut-off', 'timeFrame': 'up to 70 weeks', 'description': 'Overall survival was defined as the time between randomization and death. Participants who die, regardless of the cause of the death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the subject was known to be alive, or clinical cut-off date if it was earlier.\n\nData collection is ongoing and future data results will be included as available.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '27267105', 'type': 'DERIVED', 'citation': 'Siegel DS, Weisel KC, Dimopoulos MA, Baz R, Richardson P, Delforge M, Song KW, San Miguel JF, Moreau P, Goldschmidt H, Cavo M, Jagannath S, Yu X, Hong K, Sternas L, Zaki M, Palumbo A. Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials. Leuk Lymphoma. 2016 Dec;57(12):2833-2838. doi: 10.1080/10428194.2016.1177181. Epub 2016 Jun 7.'}, {'pmid': '24421329', 'type': 'DERIVED', 'citation': 'Richardson PG, Siegel DS, Vij R, Hofmeister CC, Baz R, Jagannath S, Chen C, Lonial S, Jakubowiak A, Bahlis N, Song K, Belch A, Raje N, Shustik C, Lentzsch S, Lacy M, Mikhael J, Matous J, Vesole D, Chen M, Zaki MH, Jacques C, Yu Z, Anderson KC. Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study. Blood. 2014 Mar 20;123(12):1826-32. doi: 10.1182/blood-2013-11-538835. Epub 2014 Jan 13.'}, {'pmid': '23243282', 'type': 'DERIVED', 'citation': 'Richardson PG, Siegel D, Baz R, Kelley SL, Munshi NC, Laubach J, Sullivan D, Alsina M, Schlossman R, Ghobrial IM, Doss D, Loughney N, McBride L, Bilotti E, Anand P, Nardelli L, Wear S, Larkins G, Chen M, Zaki MH, Jacques C, Anderson KC. Phase 1 study of pomalidomide MTD, safety, and efficacy in patients with refractory multiple myeloma who have received lenalidomide and bortezomib. Blood. 2013 Mar 14;121(11):1961-7. doi: 10.1182/blood-2012-08-450742. Epub 2012 Dec 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the maximum tolerated dose and effectiveness of the study drug (CC-4047) Alone Or in Combination With Low-dose Dexamethasone as treatment for patients with relapsed and refractory multiple myeloma', 'detailedDescription': 'The Phase 1 segment of the study was designed to determine the maximum tolerated dose (MTD) of single-agent pomalidomide, which was to be determined in the first cycle of treatment. Following completion of the first cycle, participants were allowed to continue the study at their assigned dose of pomalidomide.\n\nParticipants who developed progressive disease (PD) at any time, or who had not achieved at least a 25% reduction of serum myeloma (M)-protein levels (if measurable) and a 50% reduction of urine M-protein (if measurable) compared with baseline after completion of 4 cycles of pomalidomide, had the option to receive oral dexamethasone 40 mg on days 1, 8, 15, and 22 of each 28-day treatment cycle in addition to their current dose of pomalidomide. Participants with PD who chose not to add dexamethasone to pomalidomide therapy were to be discontinued from the study. Participants who chose to add dexamethasone were allowed to continue study treatment until PD developed again, unacceptable toxicity or participant withdrew consent, at which time they were to be discontinued.\n\nBased on results from the phase 1 portion, the Data Monitoring Committee confirmed 4 mg/day as MTD of pomalidomide. Therefore, the recommended starting dose of pomalidomide for Phase 2 was 4 mg/day on Days 1-21 of each 28-day cycle. In the combination treatment arm, the starting dose of dexamethasone was 40 mg once per day. For subjects who were \\> 75 years of age, the starting dose of dexamethasone was 20 mg once per day. To prevent blood clots, all participants were to be given aspirin 81-100 mg daily (commercial supply) unless contraindicated. If contraindicated, another form of anti-thrombotic therapy was provided.\n\nParticipants in the Phase II combination treatment arm could continue study treatment until PD developed, at which time they were to be discontinued. Participants in the single agent pomalidomide treatment arm who developed PD, confirmed by the IRAC, at any time had the option to receive oral dexamethasone in addition to their current dose of pomalidomide at the starting dose described above. Participants with PD who chose not to add dexamethasone to pomalidomide therapy were discontinued from study treatment. Participants who chose to add dexamethasone to pomalidomide therapy could continue study treatment until PD developed again, unacceptable toxicity or participant withdrew consent, at which point they were discontinued.\n\nUpon discontinuation from study treatment for PD or any other reason, participants were to be assessed two times per year, up to five years, for survival, second primary malignancy and subsequent anti-myeloma therapies.\n\nTwo analyses were planned during the course of the Phase 2 segment: one interim analysis (at 50% information of progression-free survival (PFS) events) and one final analysis. The Data Monitoring Commmittee recommended that Celgene personnel be unblinded based on the strength of the data. Subsequently, Celgene decided to file an application based on more current study data. The product was approved by the FDA in February 2013.\n\nSince no further analyses are required per protocol nor to support the marketing application, the study was amended to remove undue burden from patients who remain on active treatment by ending the treatment segments of this study and transferring all active patients tothe Long-term Follow-up Phase. These patients who continue to be treated with pomalidomide will be provided Pomalyst through the Celgene Patient Support Program (Pomalyst REMSTM) until disease progression, unacceptable toxicity, the investigator decides to change therapy or patient decision. Investigators will treat their patients according to the local standard of care and follow the assessments required for patients in the Long-term Follow-up Phase. These assessments include subsequent myeloma therapies, second primary malignancies and survival.\n\nThe study continues. A final analysis will be performed when the study is completed and results reported as available.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must be greater than or equal to 18 years at the time of signing the informed consent form\n* Must be able to adhere to the study visit schedule and other protocol requirements\n* Have a documented diagnosis of multiple myeloma and have relapsed and refractory disease. Patients must have received at least 2 prior therapies. Patients must have relapsed after having achieved at least stable disease for at least one cycle of treatment to at least one prior regimen and then developed PD. Patients must also have documented evidence of PD during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry (refractory disease)\n* Patients must have also undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of bortezomib (either in separate regimens or within the same regimen)\n* Measurable levels of myeloma paraprotein in serum (greater than or equal to 0.5 g/dL) or urine (greater than or equal 0.2 g/dL excreted in a 24 hour collection sample)\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2\n* Females of childbearing potential (FCBP) \\[An FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months)\\] must agree to refrain from becoming pregnant for 28 days prior to initiation of study drug, while on study drug and for 28 days after discontinuation of study drug and must agree to regular pregnancy testing during this timeframe.\n* All patients must also agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study\n* Males must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 28 days following discontinuation from this study even if he has undergone a successful vasectomy. Males must also agree to refrain from donating blood, semen or sperm during the above referenced timeframe.\n* All patients must agree not to share medication with another person.\n\nExclusion Criteria:\n\n* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form.\n* Any serious concurrent medical conditions that may make the patient non-evaluable or put the patient's safety at risk.\n* Pregnant or lactating females\n* Any of the following laboratory abnormalities:\n\n * Absolute neutrophil count (ANC) \\< 1,000 cells/mm3\n * Platelet count \\< 75,000/mm3 for patients in whom \\< 50% of bone marrow nucleated cells are plasma cells; or a platelet count \\< 30,000/mm3 for patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells\n * Serum creatinine \\> 3.0 mg/dL\n * Serum glutamic oxaloacetic transaminase/Aspartate transaminase (SGOT/AST) or Serum Glutamic Pyruvate Transaminase/Alanine transaminase (SGPT/ALT) \\> 3.0 X upper limit of normal (ULN)\n * Serum total bilirubin \\> 2.0 mg/dL\n* Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:\n\n * Basal or squamous cell carcinoma of the skin\n * Carcinoma in situ of the cervix or breast\n * Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)\n* Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection\n* Hypersensitivity to thalidomide, lenalidomide, or dexamethasone\n* Peripheral neuropathy ≥ Grade 2\n* Use of any anti-myeloma drug therapy within 14 days of the initiation of study drug treatment or use of any experimental non-drug therapy within 28 days of the initiation of study drug treatment\n* Radiation therapy within 14 days of initiation of study drug treatment Inability or unwillingness to comply with birth control requirements"}, 'identificationModule': {'nctId': 'NCT00833833', 'briefTitle': 'MTD, Safety, and Efficacy of Pomalidomide (CC-4047) Alone or With Low-dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene Corporation'}, 'officialTitle': 'A Phase I/II Multicenter, Randomized, Open Label, Dose-Escalation Study To Determine The Maximum Tolerated Dose, Safety, And Efficacy Of CC-4047 Alone Or In Combination With Low-Dose Dexamethasone In Patients Wth Relapsed And Refractory Multiple Myeloma Who Have Received Prior Treatment That Includes Lenalidomide And Bortezomib', 'orgStudyIdInfo': {'id': 'CC-4047-MM-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1: 2 mg pomalidomide', 'description': 'Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Participants with progressive disease (PD) had the option of adding dexamethasone 40 mg on Days 1, 8, 15, 22 of each 28-day cycle to the pomalidomide treatment, or discontinuing study treatment.', 'interventionNames': ['Drug: Pomalidomide', 'Drug: Dexamethasone', 'Drug: Aspirin']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1: 3 mg pomalidomide', 'description': 'Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Participants with progressive disease (PD) had the option of adding dexamethasone 40 mg on Days 1, 8, 15, 22 of each 28-day cycle to the pomalidomide treatment, or discontinuing study treatment.', 'interventionNames': ['Drug: Pomalidomide', 'Drug: Dexamethasone', 'Drug: Aspirin']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1: 4 mg pomalidomide', 'description': 'Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Participants with progressive disease (PD) had the option of adding dexamethasone 40 mg on Days 1, 8, 15, 22 of each 28-day cycle to the pomalidomide treatment, or discontinuing study treatment.', 'interventionNames': ['Drug: Pomalidomide', 'Drug: Dexamethasone', 'Drug: Aspirin']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1: 5 mg pomalidomide', 'description': 'Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Participants with progressive disease (PD) had the option of adding dexamethasone 40 mg on Days 1, 8, 15, 22 of each 28-day cycle to the pomalidomide treatment, or discontinuing study treatment.', 'interventionNames': ['Drug: Pomalidomide', 'Drug: Dexamethasone', 'Drug: Aspirin']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2: pomalidomide + dexamethasone', 'description': 'Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (determined by age) on days 1, 8, 15, and 22 of each 28-day cycle. The starting dose of dexamethasone was 40 mg for participants who were ≤ 75 years of age and 20 mg for participants who were \\> 75 years of age. Dose reduction steps for dexamethasone were provided for drug-related toxicities.', 'interventionNames': ['Drug: Pomalidomide', 'Drug: Dexamethasone', 'Drug: Aspirin']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2: pomalidomide', 'description': '4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone on days 1, 8, 15, and 22 of each 28-day cycle at the starting dose of 20 or 40 mg depending on age in addition to their current dose of pomalidomide, or to discontinue treatment.', 'interventionNames': ['Drug: Pomalidomide', 'Drug: Dexamethasone', 'Drug: Aspirin']}], 'interventions': [{'name': 'Pomalidomide', 'type': 'DRUG', 'otherNames': ['CC-4047', 'Pomalyst'], 'description': '1 mg, 2 mg, and 5 mg capsules for oral administration packaged in bottles containing a 21-day supply', 'armGroupLabels': ['Phase 1: 2 mg pomalidomide', 'Phase 1: 3 mg pomalidomide', 'Phase 1: 4 mg pomalidomide', 'Phase 1: 5 mg pomalidomide', 'Phase 2: pomalidomide', 'Phase 2: pomalidomide + dexamethasone']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['dexamethasone sodium phosphate'], 'description': 'oral dexamethasone', 'armGroupLabels': ['Phase 1: 2 mg pomalidomide', 'Phase 1: 3 mg pomalidomide', 'Phase 1: 4 mg pomalidomide', 'Phase 1: 5 mg pomalidomide', 'Phase 2: pomalidomide', 'Phase 2: pomalidomide + dexamethasone']}, {'name': 'Aspirin', 'type': 'DRUG', 'description': 'As prophylactic anti-thrombotic treatment, all participants were given aspirin 81-100 mg daily (commercial supply) unless contraindicated. If aspirin was contraindicated, participants were given another form of anti-thrombotic therapy according to hospital guidelines or physician preference.', 'armGroupLabels': ['Phase 1: 2 mg pomalidomide', 'Phase 1: 3 mg pomalidomide', 'Phase 1: 4 mg pomalidomide', 'Phase 1: 5 mg pomalidomide', 'Phase 2: pomalidomide', 'Phase 2: pomalidomide + dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Blood Cancer Institute', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute of Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Mass General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer CenterDivision of Hematology/Oncology', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic - Arizona', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Cancer Center at Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute Department of Medicine', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt. Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43210-1240', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Arthur G. James Cancer Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Center', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital and University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3A 1A1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Royal Victoria Hosptial', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Lars A Sternas, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Celgene Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celgene Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}