{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"8"}],"units":"Participants"}],"description":"Dose-limiting toxicity was defined as any of the following events assessed as related to carfilzomib, lenalidomide, or dexamethasone: Nonhematologic\n\n* ≥ Grade 2 neuropathy with pain\n* ≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, diarrhea, hyperglycemia due to dexamethasone, and rash due to lenalidomide)\n* ≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal supportive therapy\n* ≥ Grade 4 fatigue persisting \\> 7 days\n* Treatment delay for toxicity \\> 21 days\n\nHematologic\n\n* Grade 4 neutropenia (absolute neutrophil count \\[ANC\\] \\< 500/mm³) \\> 7 days\n* Febrile neutropenia (ANC \\< 1,000/mm³ with fever ≥ 38.3ºC)\n* Grade 4 thrombocytopenia (platelets \\< 25,000/mm³) for \\> 7 days despite holding treatment, or Grade 3 or 4 thrombocytopenia associated with bleeding\n* Treatment delay for toxicity \\> 21 days.\n\nThe maximum-tolerated dose was defined as the dose level below which a drug-related DLT was observed in ≥ 33% of participants in a cohort.","groups":[{"description":"Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.","id":"OG000","title":"1: CFZ 15 mg/m² + LEN 10 mg"},{"description":"Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.","id":"OG001","title":"2: CFZ 15 mg/m² + LEN 15 mg"},{"description":"Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.","id":"OG002","title":"3: CFZ 15 mg/m² + LEN 20 mg"},{"description":"Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.","id":"OG003","title":"4: CFZ 20 mg/m² + LEN 20 mg"},{"description":"Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.","id":"OG004","title":"5: CFZ 20 mg/m² + LEN 25 mg"},{"description":"Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.","id":"OG005","title":"6: CFZ 20/27 mg/m² + LEN 25 mg"}],"paramType":"NUMBER","populationDescription":"Safety population for the dose escalation portion of the study","reportingStatus":"POSTED","timeFrame":"Cycle 1, 28 days","title":"Number of Participants With Dose-limiting Toxicities","type":"PRIMARY","unitOfMeasure":"participants"}