{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.847","upperLimit":"0.999","value":"0.971"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"}],"units":"Participants"}],"description":"Disease response was defined as the proportion of patients who achieved a response of partial response or better using International Myeloma Working Group (IMWG) response criteria. Partial Response (PR) defined as 50% reduction of serum M-protein and reduction in 24h urinary M-protein by ≥90% or to \\<200mg/24h; Very Good Partial Response (VGPR) defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level \\<100mg/24h; Complete Response (CR) defined as negative immunofixation on serum and urine and, disappearance of any soft tissue plasmacytomas and, \\<5% plasma cells in BM; Stringent Complete Response (sCR) defined as normal FLC ratio and absence of clonal cells in BM by immunohistochemistry or 2-4 color flow cytometry. The Clopper and Pearson method was used to estimate the 95% CIs for the response rate at Week 12.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles.\n\n* Elotuzumab will be administered by intravenous (IV) infusion\n* Bortezomib as a subcutaneous injection\n* Lenalidomide single daily oral dose\n* Dexamethasone as oral tablets and IV infusion\n* Stem cell mobilization will be performed for all subjects at the end of Cycle 4.\n\nSubjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy.\n\nThe maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it.\n\nMaintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.","id":"OG000","title":"Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone"}],"paramType":"NUMBER","populationDescription":"The analysis dataset is comprised of 34 efficacy-evaluable participants, where it was defined as participants who were dosed, had a post-baseline scan and also had at least 4-cycles of induction.","reportingStatus":"POSTED","timeFrame":"Participants were followed up to 12 weeks.","title":"4 Cycle Response Rate","type":"PRIMARY","unitOfMeasure":"proportion of participants"}