{"groups":[{"description":"Participants received ixazomib 3 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 1 through 4, during which if the participants tolerated the initial dose, the dose was escalated to ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 5 through 26, or until documented progressive disease (PD) or intolerable toxicity, whichever occurred first (cycle length=28 days).","id":"FG000","title":"Ixazomib"},{"description":"Participants received ixazomib placebo-matching capsules, orally, once on Days 1, 8, and 15 of each cycle until Protocol Amendment 08 was implemented (cycle length=28 days).","id":"FG001","title":"Placebo"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Discontinued to Switch to Ixazomib"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Reason not Specified"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"4"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"}],"comment":"Placebo Safety Population included all participants who received at least 1 dose of placebo.","type":"Placebo Safety Population"},{"achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"}],"type":"NOT COMPLETED"}],"title":"Treatment Prior to Amendment 08"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"0"}],"type":"Reason not Specified"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lost to Follow-up"}],"milestones":[{"achievements":[{"comment":"6 participants (initially receiving ixazomib, before Protocol Amendment 08 was implemented) continued to receive ixazomib after implementation of Amendment 08 and 2 participants who received placebo before Amendment 08 switched to ixazomib after the implementation.","groupId":"FG000","numSubjects":"35"},{"groupId":"FG001","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"0"}],"comment":"Efficacy Population included all participants who received ixazomib treatment for the duration of their study participation. Participants who were randomized to the placebo arm and crossed over to the ixazomib arm upon implementation of Amendment 08 were not included.","type":"Efficacy Population"},{"achievements":[{"groupId":"FG000","numSubjects":"35"},{"groupId":"FG001","numSubjects":"0"}],"comment":"Ixazomib Safety Population included all participants who received at least 1 dose of ixazomib.","type":"Ixazomib Safety Population"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"35"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Treatment Post Amendment 08"}],"preAssignmentDetails":"Of the 31 participants who newly enrolled in this study, 10 (4 randomized to placebo and 6 to ixazomib) were enrolled before the implementation of Protocol Amendment 08, and 21 under the amendment, with all 21 receiving ixazomib as the study design was changed to a single-arm study. After Amendment 08, 2 of the 4 participants who were initially randomized to placebo crossed over to the ixazomib arm. As per planned analysis, these 4 participants were not included in the Efficacy Population.","recruitmentDetails":"A total of 37 participants (31 enrolled in this study and 6 rolled over from study C16021\\[NCT02312258\\]) with a diagnosis of newly diagnosed multiple myeloma (NDMM) not treated with stem cell transplantation (SCT) took part in the study at investigative sites in China from 24 January 2019 to 06 December 2023."}