{"analyses":[{"ciLowerLimit":"0.519","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.957","estimateComment":"Confidence interval estimated using the Clopper Pearson method.","groupIds":["OG000"],"nonInferiorityComment":"Estimation only.","nonInferiorityType":"OTHER","paramType":"Response Rate","paramValue":"0.800"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"}],"units":"Participants"}],"description":"Objective response was determined for each subject as a binary variable indicating whether the subject achieved a best overall response of partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) at any time on study treatment as determined by IMWG 2016 response criteria. Per IMWG 2016 criteria, PR is defined as at least 50% reduction of serum M-protein plus reduction in 24 hour urinary M-protein by 90% or to \\<200 mg/24h. VGPR is defined as serum/urine M-protein detectable by immunofixation but not electrophoresis OR \\>= 90% reduction in serum M protein plus urine M-protein \\<100 mg/24 h. CR is defined as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, and \\<5% plasma cells in bone marrow aspirates. sCR is defined as CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry.","groups":[{"description":"Induction (4 28-day cycles):\n\nCarfilzomib (IV) @ 20 mg/m\\^2, Day 1 of Cycle 1; @ 56 mg/m\\^2, Day 8,15 of Cycle 1; @ 56 mg/m\\^2, Day 1,8,15 of Cycles 2-4\n\nLenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4)\n\nDexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4\n\nElotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4\n\nMaintenance (28-day cycles):\n\nElotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n)\n\nLenalidomide (Oral) @ 15 mg (or last tolerated dose if \\<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)","id":"OG000","title":"KRd-Elotuzumab"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The response evaluable population is defined as all subjects who initiate treatment with elotuzumab and who have measurable disease at baseline.","reportingStatus":"POSTED","timeFrame":"From enrollment to best response while on study treatment; subjects remained on treatment until disease progression or death or unacceptable toxicity. Subjects were on treatment for a median of 12 months.","title":"Number of Subjects With an Objective Response","type":"SECONDARY","unitOfMeasure":"Participants"}