{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.1","upperLimit":"38.8","value":"11.1"},{"groupId":"OG001","lowerLimit":"3.4","upperLimit":"51.3","value":"22.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"description":"Progression free survival (PFS) is defined as the time of randomization to date of death from any cause, date of relapse/progression, or the last follow-up date, whichever comes first. The Kaplan-Meier method will be used to estimate PFS for each Study Arm. The method of Brookmeyer and Crowley will be used to construct 95% confidence interval.","dispersionType":"95% Confidence Interval","groups":[{"description":"Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.\n\nLenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule.\n\nElotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.\n\nLenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.\n\nDexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.\n\nDuring the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.","id":"OG000","title":"A: Elotuzumab + Lenalidomide at 25 mg"},{"description":"Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.\n\nLenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule.\n\nElotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.\n\nLenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.\n\nDexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.\n\nDuring the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.","id":"OG001","title":"B: Elotuzumab + Lenalidomide at 10 mg"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"An average of 8 months","title":"Percentage of Participants With Progression Free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}