{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"}],"units":"Participants"}],"description":"Toxicity was graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 4.03.\n\nDLT criteria that apply to Regimens A and B:\n\n* Grade 3 non-hematologic toxicity preventing the administration of \\> 1 dose of bortezomib or daratumumab during the 1st cycle.\n* Grade 4 or greater non-hematologic toxicity.\n* Grade 4 thrombocytopenia (platelet count \\< 25,000 cells/ mm\\^3) preventing the administration of \\> 1 dose of bortezomib or daratumumab during the 1st cycle or with clinically significant bleeding during the 1st cycle.\n* Grade 4 neutropenia (ANC \\< 500 cells/mm\\^3), lasting more than 7 days during the 1st cycle.\n* Greater than 14 days' delay to meet the criteria for the start of a new cycle (Cycle 2) due to toxicity.","groups":[{"description":"Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.","id":"OG000","title":"Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone"},{"description":"Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.","id":"OG001","title":"Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone"},{"description":"Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).","id":"OG002","title":"Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone"},{"description":"Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).","id":"OG003","title":"Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Only participants included in the DLT Analysis set were included in this analysis. The DLT Analysis Set was defined as all participants in Phase 1 that complete Cycle 1 of therapy or are discontinued due to a DLT event.","reportingStatus":"POSTED","timeFrame":"Cycle 1: Day 1 to Day 28","title":"Phase 1: Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)","type":"PRIMARY","unitOfMeasure":"Participants"}