NCT05714839: DREAMM-20

A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments

Recruiting now Phase 1, PHASE2 Last updated 23 January 2026

What this trial tests

Phase 1, PHASE2 trial testing Unconjugated belantamab antibody in Multiple Myeloma in 153 participants. Currently enrolling.

Timeline

14 June 2023

Primary endpoint
3 December 2029

3 December 2029

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	153
Start date	14 June 2023
Primary completion	3 December 2029
Estimated completion	3 December 2029
Sites	27 locations across Japan, Taiwan, United Kingdom, Poland, South Korea, Argentina, Australia, United States

Drugs / interventions tested

• Unconjugated belantamab antibody — full drug profile →
• Belantamab mafodotin (BELANTAMAB MAFODOTIN) — full drug profile →
• Unconjugated belantamab antibody and belantamab mafodotin — full drug profile →
• Unconjugated belantamab antibody in combination with pomalidomide-dexamethasone backbone, with or without belantamab mafodotin

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study consists of three parts:

* Part 1 The primary purpose of this part aims to evaluate the safety, tolerability, and clinical activity of escalating doses of single agent Unconjugated belantamab antibody in participants with refractory multiple myeloma (RRMM) who have received at least 3 prior therapies (4L+).
* Part 2 The primary purpose of this part is to evaluate the safety, tolerability, and clinical activity of different dose ratios of belantamab mafodotin in combination with Unconjugated belantamab antibody (delivered as separate drugs) in participants with RRMM who have received at least 3 prior therapies (4L+).
* Part 3: The Primary purpose of this part will evaluate the clinical activity of a selected dose of the unconjugated belantamab antibody, either alone or in combination with belantamab mafodotin alongside the standard of care (SoC) pomalidomide-dexamethasone backbone. The study will focus on patients with multiple myeloma who have undergone at least one prior line of therapy, including treatment with lenalidomide.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Novel Immunotherapies and Combinations: The Future Landscape of Multiple Myeloma Treatment.
   Morè S, Corvatta L, Manieri VM, Morsia E, et al · · 2023 · cited 13× · PMID 38004493 · DOI 10.3390/ph16111628
2. Belantamab Mafodotin: From Clinical Trials Data to Real-Life Experiences.
   Morè S, Offidani M, Corvatta L, Petrucci MT, et al · · 2023 · cited 13× · PMID 37296910 · DOI 10.3390/cancers15112948
3. Belantamab mafodotin in patients with relapsed/refractory multiple myeloma: a real-world experience.
   Hultcrantz M, Derkach A, Hassoun H, Korde N, et al · · 2025 · cited 1× · PMID 40575079 · DOI 10.1016/j.bneo.2025.100103
4. P983: DREAMM-20: A STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF BELANTAMAB FOR THE TREATMENT OF MULTIPLE MYELOMA WHEN USED AS MONOTHERAPY AND IN COMBINATION TREATMENTS
   Quach H, Fulci G, Ratia N, Clements J, et al · · 2023