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 is 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.


Treatments included in this clinical trial:

  • Belantamab Mafodotin (GSK2857916) is 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 study is being conducted in two different 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.

Each phase will be separated into smaller groups, called substudies. Each substudy will receive Belantamab Mafodotin with one of the other two anticancer therapies, with the exception of a control group in phase 2, which will only receive Belantamab Mafodotin.

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. 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 opthamalogist 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 treatments.
  • 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

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California

Scripps Green Hospital

La Jolla, CA

Upcoming Center

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Upcoming Center

Massachusetts

Dana-Farber Cancer Institute

Boston, MA

Upcoming Center

Wisconsin

UW Carbone Cancer Center University of Wisconsin Health

Madison, WI

Accepting
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