{"analyses":[{"ciLowerLimit":"0.163","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.677","estimateComment":"Confidence interval estimated using the Clopper Pearson method.","groupIds":["OG000"],"nonInferiorityComment":"Assuming the true VGPR+ rate is 40% under the null hypothesis, then this design will provide 90% power to detect a difference of 20% under the alternative hypothesis, assuming a one-sided alpha=0.10 significance level. For the originally planned enrollment of 40 subjects, if at least 21 subjects achieved VGPR or better to induction, the null hypothesis would be rejected.","nonInferiorityType":"SUPERIORITY","pValue":"0.597","pValueComment":"This p-value is only based on partial enrollment on the study. As enrollment was halted early, this p-value is descriptive in nature and cannot determine the success/failure of the trial.","paramType":"Response Rate","paramValue":"0.400","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"}],"units":"Participants"}],"description":"The primary endpoint is a binary variable determined for each subject indicating whether the subject achieved a very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) to induction treatment with KRd-Elo, as defined by the IMWG 2016 response criteria. Per IMWG 2016 criteria, 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 the disease response determined at the end of the induction part of regimen (4 cycles of KRd-Elo was planned, but some subjects progressed before the end of induction). The median length of induction was 16 weeks.","title":"Number of Participants With VGPR or Better Response to Induction","type":"PRIMARY","unitOfMeasure":"Participants"}