A study to explore the safety and clinical activity of GSK2857916 when given with pembrolizumab in study participants with relapsed/refractory multiple myeloma (DREAMM 4) Verified

What's the purpose of this trial?

This trial is testing GSK2857916 combined with Pembrolizumab in patients with relapsed/refractory myeloma. Researchers are studying whether these drugs work in myeloma, are safe, and what doses work best.

This trial is currently open and accepting patients.


What's being studied?

  • Belantamab Mafodotin (GSK2857916) is an investigational product that acts as an antibody-drug conjugate (ADC) with anti-BCMA antibody that binds to BCMA on tumor cell surfaces.
  • Pembrolizumab is a monoclonal antibody that blocks the PD-1 pathway.

What will happen during the trial?

This trial is being run in two parts. Part 1 has completed and Part 2 is now open and accepting patients.

  • Dose Escalation (Part 1) - Patients in this part of the trial will receive increasing doses of GSK2857916 combined with Pembrolizumab to help researchers determine which dose works best and is safest. These drugs will be given on the first day of each 21 day cycle. Patients can have up to 35 cycles of the study drugs, as long as they don’t develop bad side effects and their myeloma doesn’t get worse.
  • Dose Expansion (Part 2) - Patients in this part of the trial will receive the dose of GSK2857916 that is recommended based on the first phase of the trial, combined with Pembrolizumab by intravenous infusion on the first day of each 21 day cycle. Patients can have up to 35 cycles of the study drugs, as long as they don’t develop bad side effects and their myeloma doesn’t get worse.

This trial is non-randomized, and sequentially assigned, which means that the group you are placed in, and dose of the study drugs you receive will be determined by when you join the study.

This trial is open label, which means that both you and the researchers running the study will know which group you are placed in, and the dose of the study drugs you are receiving.


Additional Trial Information

Phase 1/2

Enrollment: 40 patients (estimated)

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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. Create your account or call us today for help (888) 828-2206.

  • Have relapsed or refractory multiple myeloma
  • Have already received a stem cell transplant, or been told that you aren’t eligible for one
  • Have already received at least three lines of therapy for your myeloma
View Additional Criteria

Trial Locations

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Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Accepting

Indiana

IU Simon Cancer Center Indiana University

Indianapolis, IN

Accepting

North Carolina

Levine Cancer Institute Atrium Health

Charlotte, NC

Accepting

Wisconsin

UW Carbone Cancer Center University of Wisconsin Health

Madison, WI

Accepting

Trial Links

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