Phase 3 Clinical Trial comparing the use of venetoclax combined with dexamethasone versus Pomalidomide combined with dexamethasone in Relapsed/Refractory Multiple Myeloma Patients with Translocation 11;14 CANOVA
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What's the purpose of this trial?

The goal of this clinical trial is to compare the progression free survival of multiple myeloma patients with translocation 11;14 when treated with venetoclax and dexamethasone versus pomalidomide and dexamethasone. 

This trial is currently open and accepting patients.

What will happen during the trial?

This clinical trial is separated into two different groups, or arms. Participants will be randomly placed into one of the two arms. Both arms of the trial are organized into 28 day cycles. Participants may continue to receive the study treatments unless their myeloma gets worse, they develop bad side effects, or they no longer wish to participate.

Arm 1: Participants randomized into this arm will receive Venetoclax by mouth every day, and dexamethasone by mouth (or intravenously if unable to take by mouth) weekly. 

Arm 2: Participants randomized into this arm will receive Pomalidomide by mouth on days 1-21 of each 28 day cycle. Participants will also receive dexamethasone by mouth (or intravenously if unable to take by mouth) weekly. 

All participants will have a treatment completion visit and then move into follow up.

 

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 measurable disease as described in the trial protocol.
  • have received at least two prior lines of therapy for multiple myeloma, with documented progression after last treatment. Participants must be relapsed/refractory to lenalidomide, and have previously received a proteasome inhibitor.
  • have tested positive for translocation 11;14 in a FISH assay performed by a centralized laboratory.
  • must not have previously received venetoclax, pomalidomide, or another BCL-2 inhibitor.
  • must not have received an allogeneic transplant in the previous 16 weeks, or an autologous transplant in the previous 12 weeks.
  • must not have known myeloma involvement in the central nervous system.

Additional Trial Information

Phase 3

Enrollment: 244 patients (estimated)

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