{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"52"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"52"}],"units":"Participants"}],"description":"Safety data and abnormal lab values and abnormal vital signs were collected and assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V4.03).","groups":[{"description":"INDUCTION:\n\nCycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22.\n\nCycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22.\n\nCONSOLIDATION:\n\nFour 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22.\n\nMAINTENANCE:\n\nAfter completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1.\n\nelotuzumab: Given intravenously (IV)\n\nLenalidomide: Given by IV\n\nDexamethasone: Given orally (PO) or by IV\n\nautologous stem cell transplantation","id":"OG000","title":"ERd Therapy"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All treated patients","reportingStatus":"POSTED","timeFrame":"weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation, and monthly for 24 months of Maintenance, up to 30 days after last dose of study drugs.","title":"Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety","type":"SECONDARY","unitOfMeasure":"Participants"}