{"groups":[{"description":"Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \\[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\\] and cyclophosphamide (CYC) 300 mg/m\\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \\>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.","id":"FG000","title":"Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)"},{"description":"Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \\[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\\] and cyclophosphamide (CYC) 400 mg/m\\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \\>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.","id":"FG001","title":"Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)"},{"description":"Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle and cyclophosphamide (CYC) 300 mg/m\\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \\>75 years) of a 28-day cycle until PD/death or unacceptable toxicity in participants with RRMM.","id":"FG002","title":"Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"40"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"17"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"6"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}],"type":"Study Terminated by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"6"}],"type":"Reason not Specified"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"36"},{"groupId":"FG001","numSubjects":"34"},{"groupId":"FG002","numSubjects":"78"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"8"}],"comment":"Completed=Completed Study Treatment","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"28"},{"groupId":"FG002","numSubjects":"70"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants with NDMM were enrolled in 1 of 2 arms to receive 4.0 mg ixazomib in combination with 300 or 400 mg cyclophosphamide and 40 mg dexamethasone (CCd); participants with RRMM were enrolled in 1 arm to receive ixazomib 4.0 mg CCd. All arms included a safety lead-in cohort for pharmacokinetics (PK) analysis.","recruitmentDetails":"Participants took part in the study at 23 investigative sites in Australia, Greece, Poland, Sweden and the United States from 05 March 2014 to 29 June 2018."}