The goal of this clinical trial is to determine if the combination of venetoclax, daratumumab and dexamethasone (with or without bortezomib) is safe and tolerable in patients with relapsed or refractory multiple myeloma.
This trial is currently open and accepting patients.
This study is being conducted in three different parts, and only Part 3 is currently enrolling at this time. Part 3 is organized into three different groups, or arms.
Arms F and G will receive one of two different doses of Venetoclax, Daratumumab, and Dexamethasone organized into 28 day cycles. Venetoclax will be given by mouth every day, and in one of two different dose levels. Daratumumab will be given either by subcutaneous injection weekly during the first two cycles, every other week during cycles 3-6, and once a month from cycle 6 onwards. Dexamethasone will be given intravenously initially and then by mouth weekly.
Arm H will receive Bortezomib, Daratumumab and Dexamethasone organized into 21 day cycles for cycles 1-8, and then 28 day cycles from cycle 9 onwards. Bortezomib will be given by subcutaneous injection on days 1, 4, 8, and 11 of cycles 1-8. Daratumumab will be given weekly during cycles 1-3, and then on the first day of each cycle afterwards. Dexamethasone will be given in a two days on, one day off sequence for approximately the first two weeks of cycles 1-8.
Patients may continue to receive study treatments unless their myeloma worsens, or they develop bad side effects.
There may be an opportunity for participants to be reimbursed for some of their travel expenses for study related visits. Once a participant has established care at one of the study sites, the staff will share the details of potential reimbursement.
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
You may be eligible to join this trial if you:
Phase 1/2
Enrollment: 96 patients (estimated)
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Winston-Salem, NC
Seattle, WA
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