{"analyses":[{"ciNumSides":"TWO_SIDED","estimateComment":"MTD is defined as the dose level below the lowest dose that induces DLT in at least one-third of patients. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD.","groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"OTHER","paramType":"Maximum Tolerated Dose (MTD) Level","paramValue":"3"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"6"}],"units":"Participants"}],"description":"Number of participants experiencing a dose-limiting toxicity (DLT) is reported below. Dose-limiting toxicity is graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.","groups":[{"description":"Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive the starting dose of 100 mg anakinra SQ every third day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.","id":"OG000","title":"Phase I - Dose Level 1"},{"description":"Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every other day. Participants also receive 325 mg aspirin PO per day with food on days 1-28.","id":"OG001","title":"Phase I - Dose Level 2"},{"description":"Participants receive 25 mg lenalidomide PO on days 1-21; SMM and IMM participants receive 20 mg dexamethasone PO on days 1, 8, 15, and 22; Active MM participants receive 40 mg dexamethasone PO on days 1, 8, 15, and 22. Participants also receive 100 mg anakinra SQ every day on days 1-28. Participants also receive 325 mg aspirin PO per day with food on days 1-28.","id":"OG002","title":"Phase I - Dose Level 3"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"28 days","title":"Number of Participants Experiencing a Dose-limiting Toxicity (DLT)","type":"PRIMARY","unitOfMeasure":"Participants"}