{"groups":[{"description":"Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).","id":"FG000","title":"Placebo + LenDex"},{"description":"Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).","id":"FG001","title":"Ixazomib + LenDex"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"10"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"22"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"142"},{"groupId":"FG001","numSubjects":"141"}],"type":"Reason not Specified"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"354"},{"groupId":"FG001","numSubjects":"351"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"354"},{"groupId":"FG001","numSubjects":"351"}],"type":"Intent-to-Treat (ITT) Population"},{"achievements":[{"comment":"1 participant in this arm who withdrew from the study was not included in the safety population.","groupId":"FG000","numSubjects":"349"},{"comment":"Included 4 participants from placebo who received ixazomib; 1 participant who withdrew was excluded.","groupId":"FG001","numSubjects":"354"}],"comment":"Includes all treated participants. Participants were analyzed as treated.","type":"Safety Population"},{"achievements":[{"groupId":"FG000","numSubjects":"283"},{"groupId":"FG001","numSubjects":"284"}],"comment":"Includes participants who completed treatment per protocol until disease progression or until discontinuation for unacceptable toxicity, withdrawal of consent, or death.","type":"Participants Completed Study Treatment Per Protocol"},{"achievements":[{"groupId":"FG000","numSubjects":"293"},{"groupId":"FG001","numSubjects":"296"}],"type":"Per Protocol (PP) Population"},{"achievements":[{"groupId":"FG000","numSubjects":"189"},{"groupId":"FG001","numSubjects":"191"}],"type":"Participants With Exposure of ≥ 19 Cycles"},{"achievements":[{"groupId":"FG000","numSubjects":"347"},{"groupId":"FG001","numSubjects":"335"}],"comment":"Includes all participants in the ITT population who receive at least 1 dose of any study drug, have measurable disease at baseline, and at least\n\n1 post baseline response assessment assessed by an Independent Review Committee (IRC).","type":"Response-evaluable Population"},{"achievements":[{"groupId":"FG000","numSubjects":"183"},{"groupId":"FG001","numSubjects":"178"}],"comment":"Completed=who completed the study.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"171"},{"groupId":"FG001","numSubjects":"173"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants with newly diagnosed multiple myeloma were enrolled in 1:1 ratio to receive ixazomib or placebo in addition to the background therapy of Lenalidomide and Dexamethasone (LenDex) in this study.","recruitmentDetails":"Participants took part in the study at 238 investigative sites in multiple countries from 29 April 2013 to 24 June 2022."}