{"groups":[{"description":"Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².","id":"FG000","title":"Bortezomib, Melphalan, Prednisone"},{"description":"Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².","id":"FG001","title":"Carfilzomib, Melphalan, Prednisone"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"64"},{"groupId":"FG001","numSubjects":"74"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"18"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"20"}],"type":"Non-compliance"},{"reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"14"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"8"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"54"},{"groupId":"FG001","numSubjects":"48"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"8"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"4"}],"type":"Continuing Treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"4"}],"type":"Randomized but not Dosed"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"477"},{"groupId":"FG001","numSubjects":"478"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"470"},{"groupId":"FG001","numSubjects":"474"}],"type":"Received Treatment"},{"achievements":[{"comment":"Completed treatment","groupId":"FG000","numSubjects":"290"},{"comment":"Completed treatment","groupId":"FG001","numSubjects":"280"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"187"},{"groupId":"FG001","numSubjects":"198"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Eligible participants were randomized in a 1:1 ratio. Randomization was stratified by International Staging System (ISS) stage (stage 1 versus stages 2 or 3), choice of route of bortezomib administration (intravenous \\[IV\\] versus subcutaneous \\[SC\\]), region (North America, Europe, Asia Pacific, or other), and age (\\< 75 years versus ≥ 75 years).","recruitmentDetails":"This study was conducted at 183 centers in Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Romania, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, and United States."}