(M15-654) A Phase 1/2, Multicenter, Dose-Escalation and Expansion Study of Combination Therapy with Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Subjects with Relapsed or Refractory Multiple Myeloma
This is a study of venetoclax, daratumumab, and dexamethasone with and without bortezomib combination therapy to evaluate safety, tolerability, and efficacy of these combinations in participants with relapsed or refractory multiple myeloma. The study will consist of 2 distinct parts: Part 1 includes participants with t(11;14) positive relapsed/refractory (R/R) multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd); Part 2 includes participants with R/R multiple myeloma who will receive venetoclax in combination with daratumumab, bortezomib, and dexamethasone (VenDVd). Each Part will be initiated with a dose-escalation phase. During the open-label, escalation phases, increasing doses of venetoclax with fixed doses of daratumumab and dexamethasone (Part 1a) or daratumumab, bortezomib, and dexamethasone (Part 2a) will be administered. The dose-escalation phases will be followed by either a randomized, and blinded (Part 1b) expansion phase or single-arm and open-label (Part 2b) expansion phase.