{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"16"}],"units":"Participants"}],"description":"The MTD is defined as the highest carfilzomib dose at which fewer than 33% of participants experience a treatment-related dose-limiting toxicity (DLT) during the first 28-day cycle. The number of participants who experienced a DLT is reported.\n\nDose-limiting toxicities are defined as any of the following carfilzomib-related adverse events:\n\nNonhematologic:\n\n* ≥ Grade 3 non-hematological toxicity\n* ≥ Grade 3 acute kidney injury (creatinine \\> 3 × baseline or \\> 4.0 mg/dL) lasting \\> 72 hours\n\nHematologic:\n\n* Grade 4 neutropenia (absolute neutrophil count \\[ANC\\] \\< 0.5 × 10\\^9/L) lasting for \\> 7 days\n* Febrile neutropenia (ANC \\< 1.0 × 10\\^9/L with a fever ≥ 38.3ºC) of any duration\n* Grade 4 thrombocytopenia (\\< 25 × 10\\^9/L) that persists for \\> 14 days, despite holding treatment\n* Grade 3 or 4 thrombocytopenia associated with \\> Grade 1 bleeding","groups":[{"description":"Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.","id":"OG000","title":"Carfilzomib 36 mg/m²"},{"description":"Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.","id":"OG001","title":"Carfilzomib 45 mg/m²"},{"description":"Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.","id":"OG002","title":"Carfilzomib 56 mg/m²"}],"paramType":"NUMBER","populationDescription":"The Safety population is defined as all enrolled participants who received any study treatment.","reportingStatus":"POSTED","timeFrame":"First cycle treatment over 28-days","title":"Number of Participants With Dose-limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"participants"}