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.
The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
The following is a listing of trial locations that are open and accepting patients.
This trial has active trial locations in countries outside of the United States.
Our system currently only provides clinical trial matching services for myeloma patients in the United States.
You can view this clinical trial's international locations by visiting ClinicalTrials.gov. Please be aware that the government website may include information that is inaccurate and/or out-of-date.
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