{"groups":[{"description":"Carfilzomib was administered intravenously (IV) at 20 mg/m\\^2 in Cycle 1: days 1 and 2; at 56 mg/m\\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.\n\nDexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles.","id":"FG000","title":"Kd - Carfilzomib and Dexamethasone"},{"description":"Carfilzomib was administered intravenously (IV) at 20 mg/m\\^2 in Cycle 1: days 1 and 2; at 56 mg/m\\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.\n\nDexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days.\n\nDaratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only.","id":"FG001","title":"KdD - Carfilzomib, Dexamethasone and Daratumumab"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"28"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"37"}],"type":"Decision by sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"74"},{"groupId":"FG001","numSubjects":"142"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"154"},{"groupId":"FG001","numSubjects":"312"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"153"},{"groupId":"FG001","numSubjects":"308"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"49"},{"groupId":"FG001","numSubjects":"102"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"105"},{"groupId":"FG001","numSubjects":"210"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants were randomized in 1:2 ratio to arms KD vs KdD after being stratified by 1) International Staging System (ISS) stage (Stage 1-2 vs Stage 3) at screening, 2) prior proteasome inhibitor exposure (yes/no), 3) number of prior lines of therapy (1 vs ≥ 2), and 4) prior cluster differentiation antigen 38 (CD38) antibody therapy (yes/no).","recruitmentDetails":"This study was conducted at 102 centers. 569 participants were screened and 466 were enrolled. Primary analysis (PA) data cutoff (DCO): 14-Jul-2019. Final analysis (FA) DCO: 15-Apr-2022."}