Phase 1/2 clinical trial evaluating the safety and tolerability of venetoclax combined with daratumumab and dexamethasone with or without bortezomib in relapsed or refractory multiple myeloma.

What's the purpose of this trial?

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.

What will happen during the trial?

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.

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 eligible to join this trial if you:

  • have relapsed or refractory multiple myeloma that worsened during or after your last treatment.
  • have received at least prior line of therapy for your myeloma, including an immunomodulatory drug.
  • have tested positive for translocation 11;14 on a FISH assay test performed by a centralized laboratory.
  • have not previously received treatment with venetoclax or another BCL-2 inhibitor.
  • have not previously had an allogeneic steam cell transplant, and have not had an autologous stem cell transplant in the last three months.
  • previous treatment with daratumumab or another anti CD-38 therapy is allowed as long as:
    • partial response or better was achieved.
    • therapy wasn’t discontinued because of side effects or toxicity,
    • and treatment wasn’t in the last 6 months.
  • previous treatment with bortezomib or a proteasome inhibitor is allowed as long as:
    • your disease did not respond to any proteasome inhibitors.
    • have previously achieved at least a partial response to treatment with a proteasome inhibitor. 
    • did not stop using your previous proteasome inhibitor because of side effects or toxicity.

Additional Trial Information

Phase 1/2

Enrollment: 96 patients (estimated)

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Trial Locations

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Moffitt Cancer Center Magnolia Campus

Tampa, FL

Open and Accepting


Winship Cancer Institute of Emory University

Atlanta, GA

Open and Accepting


Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

New Jersey

John Theurer Cancer Center Hackensack Meridian Health

Hackensack, NJ

Open and Accepting

North Carolina

Wake Forest Baptist Comprehensive Cancer Center Wake Forest School of Medicine

Winston-Salem, NC

Open and Accepting

Levine Cancer Institute Atrium Health

Charlotte, NC

Open and Accepting

Duke Cancer Center Duke University Medical Center

Durham, NC

Open and Accepting


Oregon Health and Science University (OHSU) Knight Cancer Institute

Portland, OR

Open and Accepting


Seattle Cancer Care Alliance

Seattle, WA

Open and Accepting
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