{"denoms":[{"counts":[{"groupId":"BG000","value":"15"}],"units":"Participants"}],"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":"BG000","title":"KRd-Elotuzumab"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"9"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"6"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"46","upperLimit":"74","value":"64"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"9"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"15"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"4"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"10"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"15"}]}],"title":"United States"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6"}],"title":"0"},{"measurements":[{"groupId":"BG000","value":"8"}],"title":"1"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"2"}]}],"description":"Measure Description: ECOG Scale of Performance Status, developed by the Eastern Cooperative Oncology Group. (0) subject is fully active, able to carry on all predisease performance without restriction; (1) subject is restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light house work, office work); (2) subject is ambulatory and capable of all self-care but unable to carry out any work activities (up and about more than 50% of waking hours)","paramType":"COUNT_OF_PARTICIPANTS","title":"ECOG at Baseline","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7"}],"title":"Stage I"},{"measurements":[{"groupId":"BG000","value":"3"}],"title":"Stage II"},{"measurements":[{"groupId":"BG000","value":"5"}],"title":"Stage III"}]}],"description":"International Staging System (ISS) - developed by the International Myeloma Working Group (IMWG).\n\nStage I indicates serum beta 2 microglobulin (SB2M)\\<3.5 mg/L, serum albumin\\>=3.5 g/dL;\n\nStage II indicates SB2M\\<3.5 mg/L and serum albumin\\<3.5 g/dL, OR SB2M 3.5-5.5 mg/L, irrespective of serum albumin;\n\nStage III indicates SB2M\\>5.5 mg/L","paramType":"COUNT_OF_PARTICIPANTS","title":"Baseline ISS Stage","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"}],"title":"Stage I"},{"measurements":[{"groupId":"BG000","value":"5"}],"title":"Stage II"},{"measurements":[{"groupId":"BG000","value":"5"}],"title":"Stage III"}]}],"description":"Revised International Staging System (R-ISS) - revision developed by the International Myeloma Working Group (IMWG).\n\nStage I indicates serum beta 2 microglobulin (SB2M)\\<3.5 mg/L, serum albumin\\>=3.5 g/dL, standard risk chromosomal abnormalities (CA) by iFISH, normal LDH;\n\nStage II indicates not R-ISS stage I or stage III;\n\nStage III indicates SB2M\\>5.5 mg/L and either high-risk CA by iFISH or high LDH","paramType":"COUNT_OF_PARTICIPANTS","title":"Baseline R-ISS Stage","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"13"}],"title":"Prior lenalidomide"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"No prior lenalidomide"}]}],"description":"Indicates whether the subject had previously received lenalidomide","paramType":"COUNT_OF_PARTICIPANTS","title":"Prior Lenalidomide Exposure","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"14"}],"title":"Prior Bortezomib"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"No Prior Bortezomib"}]}],"description":"Indicates whether the subject had previously received bortezomib","paramType":"COUNT_OF_PARTICIPANTS","title":"Prior Bortezomib Exposure","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"12"}],"title":"Prior ASCT"},{"measurements":[{"groupId":"BG000","value":"3"}],"title":"No Prior ASCT"}]}],"description":"Indicates whether the subject had previously undergone autologous stem cell transplant (ASCT)","paramType":"COUNT_OF_PARTICIPANTS","title":"Prior ASCT","unitOfMeasure":"Participants"}]}