{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"}],"units":"Participants"}],"description":"MTD was highest dose of ixazomib given with combination drugs, at which \\<=1 of 6 participants experienced dose-limiting toxicity (DLT) during Cycle 1 of Phase 1. DLT defined as any of following considered possibly related to therapy: Grade 4 neutropenia (absolute neutrophil count \\[ANC\\] \\<500 cell per cubic millimeter \\[cells/mm\\^3\\]) for \\>7 days; Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia for \\>7 days; Grade 3 thrombocytopenia with clinically significant bleeding; platelet count \\<10,000/mm\\^3; Grade 2 peripheral neuropathy with pain or \\>=Grade 3 peripheral neuropathy; \\>=Grade 3 nausea/emesis, diarrhea controlled by supportive therapy; any \\>=Grade 3 nonhematologic toxicity except Grade 3 arthralgia/myalgia; or \\<1 week Grade 3 fatigue; delay in initiation of the subsequent therapy cycle by \\>14 days; \\<=80% lenalidomide doses administered due to other \\>=Grade 2 combination study drug-related nonhematologic toxicities requiring therapy discontinuation.","groups":[{"description":"Ixazomib 3 mg or 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy at the dose tolerated at the end of induction until progressive disease or unacceptable toxicity. The maximum number of cycles received was 83 cycles (approximately up to 2037 days).","id":"OG000","title":"Phase 1: All Participants"}],"paramType":"NUMBER","populationDescription":"DLT-evaluable population included all participants who received all Cycle 1 doses of MLN9708 and completed Cycle 1 procedures, or experienced a DLT in Cycle 1 in Phase 1.","reportingStatus":"POSTED","timeFrame":"Cycle 1 (21 days)","title":"Phase 1: Maximum Tolerated Dose (MTD)","type":"PRIMARY","unitOfMeasure":"mg"}