{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"description":"Dose Limiting Toxicity (DLT) is defined as any of the toxicities in Section 7.3 that are at least possibly related to either Pomalidomide or MLN9708 that occur during cycle 1. Toxicity graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.03. The highest dose level that produces 1/6 dose-limiting toxicities (DLTs) in course 1 will be the maximum tolerated dose (MTD). The RP2D of ixazomib and pomalidomide will generally be the MTD, but it may be less than the MTD based on a review of available data/cumulative toxicities from phase I.","groups":[{"description":"Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Dose Level #1: 3mg MLN9708"},{"description":"Patients receive ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Dose Level #2: 4mg MLN9708"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Patients were considered evaluable for DLT if receiving at least 75% of both Pomalidomide and MLN9708 and followed for the full 28 days during cycle 1 or experience a DLT. All patients who are not evaluable for DLT were replaced.","reportingStatus":"POSTED","timeFrame":"From the initial treatment to Day 28 (Cycle #1)","title":"Number of Patients With Dose-Limiting Toxicities (Phase I)","type":"PRIMARY","unitOfMeasure":"Participants"}