{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"6"}],"units":"Participants"}],"description":"A Dose Review Team (DRT) evaluated DLTs to determine the recommended dose (RD) of Durvalumab to use in the Expansion Period. A DLT was defined as: a. Grade 4 neutropenia for \\>= 5 days. b. Grade 3 neutropenia associated with fever (≥ 38.5°C / 101.3°F) of any duration. c. Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding, or platelets transfusion. d. Grade 4 hematologic toxicity that does not resolve to baseline level \\<=72 hours. e. Grade 4 anemia, unexplained by underlying disease. f. Any nonhematologic toxicity Grade ≥ 3 except for alopecia and nausea. g. Treatment interruption \\>= 2 weeks due to AE. If ≤ 1 of the 6 initial participants in each cohort experience a DLT during cycle 1, the RD was Durvalumab 1500 mg; If \\>=2 of the 6 initial participants in any cohort experience a DLT during cycle 1, the maximum tolerated dose (MTD) was exceeded and the dose level of Durvalumab was de-escalated to 750 mg","groups":[{"description":"High risk, transplant non-eligible \\[TNE\\], newly diagnosed multiple myeloma (NDMM) participants who were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \\[CrCl\\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.","id":"OG000","title":"Cohort A: High Risk, TNE"},{"description":"\\>= 65 years old, transplant non-eligible \\[TNE\\], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \\[CrCl\\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles.","id":"OG001","title":"Cohort B: >=65 Years Old, TNE"},{"description":"High risk, post-transplant NDMM participants were administered the following as maintenance therapy: • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle.","id":"OG002","title":"Cohort C: High Risk, Post-transplant"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Dose-Determining Population consists of all participants from the Safety Population of the Dose Determining Period who received at least one dose of Durvalumab. Cohort B's Dose-Determining Population was 7 participants as one was considered non-evaluable and was therefore replaced per protocol","reportingStatus":"POSTED","timeFrame":"First treatment cycle: Day 1 to Day 28","title":"Participants With Dose-Limiting Toxicities (DLTs) During the Dose-Determining Timeframe (Day 1 - Day 28)","type":"PRIMARY","unitOfMeasure":"Participants"}