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

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 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.

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.

  • 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.

Additional Trial Information

Phase 2

Enrollment: 464 patients (estimated)

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Published Results

DREAMM-5 Study: Investigating the Synergetic Effects of Belantamab Mafodotin Plus Inducible T-Cell Co-Stimulator Agonist (aICOS) Combination Therapy in Patients with Relapsed/Refractory Multiple Myeloma

December 13, 2021

A total of 23 patients treated with belamaf + aICOS were included in this preliminary analysis. The median (range) of prior lines of therapy was 5 (3–10). The majority of patients (21 [91%]) had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0–1 and the remainder (2 [9%]) had an ECOG PS of 2. Thirty percent of patients (n=7) had high-risk cytogenetics, and no patients had extramedullary disease.

The preliminary overall clinical response rate for the total population was 48% (n=11; 95% CI: 26.8–69.4), with 26% of patients (n=6) achieving a very good partial response or better (Table).

Nineteen patients (83%) of the total population experienced an adverse event (AE) related to study treatment and 12 patients (52%) experienced Grade ≥3 AEs related to study treatment. A total of 16 patients (70%) in the total population experienced any grade ocular AEs while 9 patients (39%) had Grade ≥3 ocular AEs related to study treatment. Only 2 patients (1 each from cohorts A and B) permanently discontinued study treatment due to AEs. Dose reductions and delays were used to manage AEs in several patients (Table).

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

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.


Scripps Green Hospital

San Diego, CA

Not Yet Accepting


Winship Cancer Institute Emory University

Atlanta, GA

Open and Accepting


Simon Cancer Center Indiana University

Indianapolis, IN

Open and Accepting


Dana-Farber Cancer Institute (Main)

Boston, MA

Open and Accepting


MD Anderson Cancer Center The University of Texas

Houston, TX

Not Yet Accepting


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