What's the purpose of this trial?
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.
What will happen during the trial?
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.
You may be able to join this trial if you:
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:
- have a diagnosis of relapsed/refractory multiple myeloma, and your myeloma has tested positive for translocation 11;14.
- have received at least one prior line of therapy for your multiple myeloma.
- have not previously received carfilzomib.
- have not previously received venetoclax or another BCL-2 inhibitor.
- have not had an allogeneic stem cell transplant in the previous six months, and have not had an autologous transplant in the previous three months.
Additional Trial Information
Phase 2
Enrollment: 120 patients (estimated)
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