{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"59"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"75"}],"units":"Participants"}],"description":"PE planned for after at least 103 events (progression/death); analyzed at 111 events. Those who neither progressed nor died were censored on the date of last adequate tumor assessment (ATA), which requires both serum and urine M-protein tests. If no post-baseline tumor assessments/no death, then censored on randomization day. Response assessed: Day 1 (± 7 days) each cycle; 30 and 60 days post treatment. Modified IMWG criteria used. Progression: Any of following: Increase of 25% in serum and/or urine M-component; if no measurable serum, urine M-protein levels, then difference between involved and uninvolved free light chain (FLC) levels (absolute increase \\> 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). New bone lesions or soft tissue plasmacytomas or increase in size of existing lesions, plasmacytomas. Development of hypercalcemia attributed solely to plasma cell proliferative disorder. First dose occurs within 3 days of randomization.","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":"OG000","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":"OG001","title":"Bortezomib + Dexamethasone"}],"paramType":"NUMBER","populationDescription":"Intent to treat (ITT), all randomized participants were analyzed.","reportingStatus":"POSTED","timeFrame":"Randomization until 111 events, up to May 2014, approximately 2 years","title":"Number of Investigator-Assessed Progression-free Survival Events From Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants","type":"PRIMARY","unitOfMeasure":"Events (progression or death)"}