Outcomes
tumor, DLTs, Cancer
ADVERSE EVENT, TUMOR, MYELOMA, SECONDARY, MINIMAL RESIDUAL DISEASE, CANCER
Primary endpoints for Phase 1 were safety and tolerability, which were assessed according to DLTs (at the end of Cycle 1) as well as AEs, serious AEs (SAEs), and laboratory abnormalities (graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03). For Phase 2, the primary endpoint was overall response rate (ORR), defined as the proportion of patients with complete response (CR; including stringent CR [sCR]), very good partial response (VGPR), and partial response (PR), as assessed by investigators using the International Myeloma Working Group response criteria.Key secondary efficacy endpoints included clinical benefit rate (CBR), duration of response (DOR), time to response (TTR), progression‐free survival (PFS), overall survival (OS), pharmacokinetics (PK), and immunogenicity. Additional exploratory endpoints were minimal residual disease in patients achieving CR, and immune and tumor cell phenotyping.Efficacy analyses for Phase 2 were performed for the intent‐to‐treat (ITT)/randomized population. ORR, CBR, PFS, and OS were separately assessed according to previous exposure to daratumumab. Analysis of exposure and safety parameters were performed for the all‐treated/safety population, which consisted of all patients who received at least one dose or a part of a dose of the study treatments during Phase 1 or 2 (patients were analyzed separately by phase). Pharmacokinetic analysis was performed on all patients from the all‐treated population with at least one measurable drug concentration post‐baseline.