{"groups":[{"description":"Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to end of treatment (EOT) (up to approximately 42.9 months).","id":"FG000","title":"Ixazomib+ Lenalidomide + Dexamethasone"},{"description":"Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).","id":"FG001","title":"Placebo + Lenalidomide + Dexamethasone"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Site Terminated by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"14"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"3"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"81"},{"groupId":"FG001","numSubjects":"82"}],"type":"Reason not specified"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"360"},{"groupId":"FG001","numSubjects":"362"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"360"},{"groupId":"FG001","numSubjects":"362"}],"comment":"ITT population was defined as all randomized participants.","type":"Intent-to-Treat (ITT) Population"},{"achievements":[{"groupId":"FG000","numSubjects":"361"},{"groupId":"FG001","numSubjects":"359"}],"comment":"Safety population included all randomized participants who received at least 1 dose of any study drug, regardless of their randomized treatment.","type":"Safety Population"},{"achievements":[{"groupId":"FG000","numSubjects":"345"},{"groupId":"FG001","numSubjects":"348"}],"comment":"Response-Evaluable population included all participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post-baseline response assessment.","type":"Response Evaluable Population"},{"achievements":[{"groupId":"FG000","numSubjects":"259"},{"groupId":"FG001","numSubjects":"263"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"101"},{"groupId":"FG001","numSubjects":"99"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants with a diagnosis of relapsed and/or refractory multiple myeloma were enrolled in 1 of 2 treatment groups: Ixazomib 4 mg or Ixazomib placebo-matching tablets in combination with lenalidomide, and dexamethasone.","recruitmentDetails":"Participants were enrolled at 187 sites in Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Republic of Korea, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Singapore, Spain, Sweden, Turkey, United Kingdom and US from 01 August 2012 to 08 February 2022."}