DREAMM5

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

What's the purpose of the 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.

Trial status

Accepting patients

Phase
Phase 2
Enrollment
464
Last Updated
2 months ago
Am I Eligible

Participating Centers

There are 10 centers participating in this trial. Enter a location below to find the closest center.

Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Belantamab Mafodotin is an antibody-drug conjugate (ADC) that binds to BCMA on tumor cell surfaces. Belantamab Mafodotin is used in the treatment of multiple myeloma.  
  • Dexamethasone is a corticosteroid that prevents the release of substances in the body that cause inflammation, and is given in conjunction with some cancer treatments.
  • Dostarlimab is a monoclonal antibody approved for use in treating endometrial cancer, but being studied for use in other cancers.
  • Feladilimab is an investigational monoclonal antibody being studied for use in several different cancers.
  • GSK3174998 is a monoclonal antibody that targets and binds to the OX40 protein found on the surface of activated T-cells.
  • Isatuximab is a type of drug called a monoclonal antibody. Isatuximab targets a protein called CD38, which is present in high numbers on the surface of multiple myeloma cells, as well as on certain other types of cells, such as red blood cells.
  • Lenalidomide is an oral immunomodulatory drug that may help the immune system kill cancer cells. It may also prevent the growth of new blood vessels that tumors need to grow.
  • Nirogacestat is a selective, reversible, non-competitive gamma-secretase inhibitor drug that is expected to increase the anti-tumor effectiveness of drugs like elranatamab
  • Pomalidomide is a kind of medication called an immunomodulatory agent that promotes an immune response to help slow tumor growth. Pomalidomide is used in the treatment of several different indications.

Arms / Cohorts

Explore eligibility, treatments and learn more about potential cohorts.

Accepting patients

Belantamab Mafodotin

Accepting patients

Belantamab Mafodotin + GSK3174998

Accepting patients

Belantamab Mafodotin + Feladilimab

Published Results

Explore published results and other resources associated with this clinical trial (including press releases, news articles and videos).

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

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).

2 years ago Read more

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