{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"226"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"description":"For the purposes of this study, toxicity will be defined as inability to receive 4 cycles of IRD consolidation due to toxicity.","groups":[{"description":"Consolidation therapy will begin between Day 80 and Day 120 following ASCT and will consist of four 28-day cycles of IRD (ixazomib, lenalidomide, \\& dexamethasone). Barring dose modifications for toxicity, 4 mg of ixazomib and 40 mg of dexamethasone will be administered on Days 1, 8, and 15, and 15 mg of lenalidomide will be administered on daily on Days 1-21.","id":"OG000","title":"Consolidation: Ixazomib, Lenalidomide, & Dexamethasone"},{"description":"Ixazomib will be administered on Days 1, 8, and 15 of a 28-day cycle at a starting dose of 4 mg until patient progresses or experiences an unacceptable toxicity.\n\n09/23/2019: Upon review of the interim analysis, there will be no further randomizations into the maintenance portion of the trial. All patients will be enrolled into the lenalidomide arm with the exception of those who discontinue lenalidomide during the consolidation phase due to toxicity. Patients who discontinue lenalidomide may be enrolled into the ixazomib arm following approval from the principal investigator.","id":"OG001","title":"Maintenance Arm 1: Ixazomib"},{"description":"Lenalidomide will be administered daily continuously for a 28-day cycle at a starting dose of 10 mg. If lenalidomide is tolerated well (i.e. no dose modification required) during the first three cycles, lenalidomide dose will be increased to 15 mg daily and will continue until patient progresses or experiences an unacceptable toxicity.","id":"OG002","title":"Maintenance Arm 2: Lenalidomide"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Only participants in the consolidation portion of the trial are evaluable for this outcome measure. 10 patients in consolidation were not evaluable for this outcome because they discontinued prior to 4 cycles of IRD for reasons other than toxicity.","reportingStatus":"POSTED","timeFrame":"After 4 cycles of IRD consolidation treatment (approximately Day 112 of consolidation treatment)","title":"Toxicity of IRD Consolidation","type":"SECONDARY","unitOfMeasure":"Participants"}