DREAMM20

A Phase 1/2 Open-label, Multicentre, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Clinical Activity of Belantamab as Monotherapy and in Combination With Other Treatments in Participants With Multiple Myeloma

What's the purpose of the trial?

The study consists of three parts * Part 1: The primary purpose of this part is to determine the safety, and recommended part 2 dose of belantamab (bela) in participants with relapsed or refractory multiple myeloma (RRMM). * Part 2: The primary purpose of this part is to determine safety, tolerability and percentage of adverse events (AEs) that happen to eyes in participants with RRMM treated with bela in combination with other treatments. * Part 3: The primary objective of this part is to assess the safety, tolerability and rate of ocular AEs in participants with transplant-ineligible newly diagnosed multiple myeloma (TI-NDMM) treated with either belantamab mafodotin (belamaf) or bela in combination with other treatments.
Trial status

Accepting patients

Phase
Phase 1/2
Enrollment
55
Last Updated
4 weeks ago

Participating Centers

There are 2 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
  • Belantamab Mafodotin

Published Results

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

Belantamab Monotherapy Demonstrates Safety and Durable Responses for Heavily Pretreated R/R MM: Results From DREAMM-20

In this open-label dose-escalation study, 18 patients with ≥3 prior lines of therapy (94% triple-class exposed) were treated with belantamab monotherapy IV every 2 weeks at doses of 300 mg, 900 mg, or 2000 mg (n = 6 per cohort). The median age was 76 years (range, 42 to 86), and 2 patients had received prior BCMA-directed therapy.

The median duration of exposure was 63.5 days, and no dose-limiting toxicities or adverse reactions led to treatment discontinuation. The most common treatment-related adverse events were infusion reactions (22%) and hematologic events. The most common grade 3 or higher adverse events were neutrophil count decrease (22%) and anemia (17%).

The overall response rate (ORR) was 28%, including 2 very good partial responses and 3 partial responses. Disease was observed in another five patients (28%).

1 month ago Read more

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