{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.1","upperLimit":"13.9","value":"9.9"},{"groupId":"OG001","lowerLimit":"5.0","upperLimit":"11.1","value":"8.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"54"}],"units":"Participants"}],"description":"PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase \\> 100 mg/L); Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder. Randomized participants with at least 1 FcγRIIIa V allele were a sub-set of all randomized participants.","dispersionType":"95% Confidence Interval","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":"MEDIAN","populationDescription":"All randomized participants who had at least one FcγRIIIa V allele were analyzed.","reportingStatus":"POSTED","timeFrame":"Randomization until 111 events, up to May 2014, approximately 2 years","title":"Median Progression-free Survival Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause, in Randomized Participants With at Least One FcγRIIIa V Allele","type":"SECONDARY","unitOfMeasure":"Months"}