The goal of this clinical trial is to determine the safety, effectiveness, and tolerability of venetoclax in combination with carfilzomib and dexamethasone. This combination is being evaluated in participants with relapsed/refractory multiple myeloma.
This trial is currently open and accepting patients.
This trial is organized into four parts, with only part 4 currently enrolling. Part 4 of this clinical trial is organized into three different groups, or arms. Participants will be randomly assigned into one of the three arms. This trial is open- label, which means that both researchers and trial participants will know which arm they are placed in, and which study treatments they will be receiving. Each arm is organized into 28 day cycles, and participants may continue to receive the study treatments as long as they don’t develop bad side effects and their myeloma doesn’t get worse.
Arm A: Participants in this arm will receive Venetoclax, Carfilzomib, and Dexamethasone. Venetoclax will be given by mouth, every day, at a lesser dose than Arm B will receive. Carfilzomib will be given by intravenous infusion weekly during the first three weeks of each cycle. Dexamethasone will be given either by mouth or by intravenous infusion weekly (cycles 1-9), and then weekly for the first three weeks of each cycle (cycles 10 and onwards).
Arm B: Participants in this arm will receive Venetoclax, Carfilzomib, and Dexamethasone. Venetoclax will be given by mouth, every day, at a higher dose than Arm A will receive. Carfilzomib will be given by intravenous infusion weekly during the first three weeks of each cycle. Dexamethasone will be given either by mouth or by intravenous infusion weekly (cycles 1-9), and then weekly for the first three weeks of each cycle (cycles 10 and onwards).
Arm C: Participants in this arm will receive Carfilzomib by intravenous infusion weekly during the first three weeks of each cycle. They will also receive Dexamethasone either by mouth or by intravenous infusion weekly (cycles 1-9), and then weekly for the first three weeks of each cycle (cycles 10 and onwards).
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 able to join this trial if you:
Phase 2
Enrollment: 120 patients (estimated)
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Birmingham, AL
Philadelphia, PA
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