Platform Study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination with Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM5) Verified

What's the purpose of this trial?

This trial is testing which types of anticancer treatments can be safely combined with Belantamab Mafodotin (GSK2857916). It is also testing which doses of Belantamab Mafodotin combined with anticancer treatments are better at treating myeloma than Belantamab Mafodotin on its own.

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.
  • GSK3174998 is a monoclonal antibody that targets and binds to the OX40 protein found on the surface of activated T-cells.
  • GSK3359609 is a monoclonal antibody that targets and binds to the Inducible T cell Co-Stimulator (ICOS) receptor found on the surface of T cells.

What will happen during the trial?

This trial is randomized, which means that you will be randomly placed into different groups, and this will determine which study drugs you receive.

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 which drugs you will be receiving.

This trial is organized into a series of sub-studies. Each individual sub-study will be testing the combination of Belantamab Mafodotin and one of the other anti-cancer therapies being used. Participants will be randomized in this study, which means that neither the patients nor the clinical trial team will be able to choose which sub-study, dose-level, or phase they participate in. Each individual sub-study will be conducted in two phases:

  • Phase 1: Dose Exploration – this phase will look to find the safest doses of Belantamab Mafodotin in combination with other anticancer treatments.
  • Phase 2: Cohort Expansion – this phase will use the best and safest doses of Belantamab Mafodotin and the anticancer treatments determined by Phase 1 of the study. These doses will be given to a larger number of patients so that researchers can gather more information about how well the combinations work in treating multiple myeloma. Some patients in this part of the study will receive Belantamab Mafodotin alone (not in combination with another anti-cancer treatment).

Treatments in this trial are organized in 21 day cycles, with patients receiving Belantamab Mafodotin and the other anticancer treatments on day 1 of each cycle as intravenous infusions. In some sub-studies, the second anti-cancer treatment may be in the form of tablets for patients to take both at the hospital and at home between hospital visits.  Patients can continue to receive experimental treatments until their myeloma gets worse, or they develop bad side effects.

During the first four cycles of this trial, patients must also visit an opthalmologist for eye exams every three weeks. During the entire time patients are a part of this trial, they may not wear contact lenses.


Additional Trial Information

Phase 2

Enrollment: 464 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 been diagnosed with Multiple Myeloma
  • Have received at least three prior lines of therapy.
  • Have not received an autologous transplant in the past 100 days.
  • Have not previously had an allogeneic transplant.
  • Have not previously had Belantamab Mafodotin.
View Additional Criteria

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

Scripps Green Hospital

La Jolla, CA

Not Yet Accepting

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Open and Accepting

Indiana

IU Simon Cancer Center Indiana University

Indianapolis, IN

Not Yet Accepting

Massachusetts

Dana-Farber Cancer Institute

Boston, MA

Not Yet Accepting

Texas

MD Anderson Cancer Center The University of Texas

Houston, TX

Not Yet Accepting

Wisconsin

UW Carbone Cancer Center University of Wisconsin Health

Madison, WI

Open and Accepting

Trial Links

Read the latest news and updates on this trial.

FDA Panel Supports Belantamab Mafodotin for Relapsed/Refractory Myeloma

July 14, 2020

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to 0 in favor of approving belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma who have previously received at least 4 prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and a CD38-directed antibody.

Read more
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