{"groups":[{"description":"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 \\& 2: Days 1, 8 \\& 15; Cycles 3-8: Days 1 \\& 11; Cycle 9+: Days 1 \\& 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m\\^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1\\& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1\\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \\&11; Cycles 9+; Days 1 \\& 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1\\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \\&11; Cycles 9+; Days 1 \\& 15); Until criteria met for discontinuation","id":"FG000","title":"Elotuzumab + Bortezomib + Dexamethasone"},{"description":"Bortezomib: Solution; IV; 1.3 mg/m\\^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug","id":"FG001","title":"Bortezomib + Dexamethasone"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"52"},{"groupId":"FG001","numSubjects":"35"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"14"}],"type":"study drug toxicity"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"11"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"5"}],"type":"subject request to discontinue treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"5"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"4"}],"type":"non-specified"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"poor/non-compliance"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"no longer meets study criteria"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"77"},{"groupId":"FG001","numSubjects":"75"}],"type":"STARTED"},{"achievements":[{"comment":"1 randomized to E-Bd but received Bd. Included in E-Bd group for efficacy and Bd group for safety","groupId":"FG000","numSubjects":"76"},{"comment":"1 randomized to E-Bd but received Bd. Included in E-Bd group for efficacy and Bd group for safety","groupId":"FG001","numSubjects":"74"}],"type":"Received Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"comment":"Completed = Still on treatment","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"77"},{"groupId":"FG001","numSubjects":"75"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"185 participants were enrolled, 152 participants were randomized. Reasons not randomized: 23 no longer met study criteria, 5 withdrew consent, 2 died, 3 had poor/non-compliance. 150 were treated with study drug. 2 participants were not treated: 1 withdrawal by subject and 1 physician decision."}