{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"}],"units":"Participants"}],"description":"MTD was highest dose of Ixazomib, at which \\<=1 of 6 participants experienced dose-limiting toxicity (DLT). DLT was defined using National Cancer Institute Common Terminology Criteria for Adverse Events, v 4.03 as: Grade 4 neutropenia (absolute neutrophil count \\<500 cells/mm\\^3) for \\>7 days;Grade 3 neutropenia with fever or infection;Grade 4 thrombocytopenia (platelets \\< 25,000/mm\\^3) 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;Grade 3 QTc prolongation (QTc \\>500 msec);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 \\>2 weeks;other \\>=Grade 2 study drug-related nonhematologic toxicities requiring therapy discontinuation, considered possibly related to therapy as assessed by Investigator.","groups":[{"description":"Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.","id":"OG000","title":"Dose Escalation Cohort: Ixazomib 4.0 mg"},{"description":"Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone 40 mg, tablet, orally was added once on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. If there was no hematologic response the participant was discontinued. Participants with hematologic response continued treatment up to maximum 12 cycles.","id":"OG001","title":"Dose Escalation Cohort: Ixazomib 5.5 mg"}],"paramType":"NUMBER","populationDescription":"DLT-evaluable population included all participants who received all Cycle 1 doses of ixazomib or experienced a DLT in Cycle 1.","reportingStatus":"POSTED","timeFrame":"Cycle 1 (28 days)","title":"Maximum Tolerated Dose (MTD) of Ixazomib","type":"PRIMARY","unitOfMeasure":"mg"}