Belantamab for Multiple Myeloma

(DREAMM-20 Trial)

Recruiting at 22 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: GlaxoSmithKline

Must not be taking: Antibiotics, Antivirals, Antifungals, others

Disqualifiers: Amyloidosis, POEMS syndrome, Leukemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment called belantamab for people with multiple myeloma, a type of blood cancer. It targets those whose disease has returned or worsened after at least three other treatments. The study has two parts: one examines belantamab alone, and the other investigates belantamab combined with belantamab mafodotin, an antibody-drug conjugate. Individuals who have tried various treatments for multiple myeloma but still face frequent issues might be suitable for this trial. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had certain treatments like monoclonal antibodies or investigational agents within 30 days or systemic anti-myeloma therapy within 14 days before starting the study drugs. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that belantamab mafodotin, used alone or with another drug, is generally safe for patients with relapsed or hard-to-treat multiple myeloma. One study found that patients who had undergone several treatments before trying belantamab mafodotin tolerated it fairly well. The treatment proved effective for many in real-world settings, not just in strict clinical trials.

Some patients experienced side effects, which is common with many cancer treatments, but these were manageable. The safety data indicated that the treatment did not cause serious problems for most patients. However, since this is an early-stage trial, researchers focus on finding the safest and most effective ways to use these drugs together. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Belantamab is unique because it targets and binds to the B-cell maturation antigen (BCMA) on multiple myeloma cells, a different approach compared to standard chemotherapy and proteasome inhibitors like bortezomib. Researchers are excited about belantamab mafodotin, an antibody-drug conjugate, as it delivers a potent chemotherapy directly to the cancer cells, potentially reducing damage to healthy cells. This targeted mechanism could offer a more effective treatment with fewer side effects, making it a promising option for patients with relapsed or refractory multiple myeloma.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Research shows that belantamab mafodotin may help treat multiple myeloma, a type of blood cancer. In earlier studies, this drug reduced the risk of death by 42% for patients whose cancer returned after treatment. About 35.6% of patients saw their cancer respond to the treatment, with some experiencing a complete response, meaning no signs of cancer were found. In this trial, participants will receive belantamab in different treatment arms. One arm involves dose escalation of belantamab monotherapy, while another explores belantamab in combination with a fixed dose of belantamab mafodotin delivered as separate drugs. These results suggest that belantamab could be a good option for people who have not had success with other therapies. ^{1 6 7 8 9}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

This trial is for individuals with Multiple Myeloma who've had at least three prior treatments, including an immunomodulating agent, a proteasome inhibitor, and an anti-CD38 mAb. They should have no active infections, be in relatively good health (ECOG-PS of 0 to 2), and meet specific laboratory criteria indicating the presence of myeloma.

Inclusion Criteria

My transplant was over 100 days ago.

I do not have any current infections.

I can take care of myself and am up and about more than half of my waking hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive escalating doses of single agent belantamab until progressive disease

Until progressive disease

Treatment Part 2

Participants receive belantamab in combination with a fixed dose of belantamab mafodotin until progressive disease

Until progressive disease

Optional Extension

Participants have the option to receive treatment with single agent belantamab mafodotin after progressive disease

Until progressive disease

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Belantamab
• Belantamab Mafodotin
• Dexamethasone
• Lenalidomide
• Standard of Care

Trial Overview The study tests Belantamab as a single agent and in combination with Belantamab mafodotin in patients with refractory Multiple Myeloma. It aims to find safe dosages while assessing the drugs' effectiveness against this type of cancer after several other treatments have failed.

How Is the Trial Designed?

Group I: Part 2: Belantamab and belantamab mafodotin (delivered as separate drugs) dose range finding Experimental Treatment 1 Intervention

Participants with RRMM will receive belantamab in combination with a fixed dose of belantamab mafodotin (delivered as separate drugs)

Group II: Part 1b: Optional belantamab mafodotin Experimental Treatment 1 Intervention

Participants enrolled in Part 1 and Part 2 will be dosed until PD after which they will have the option to receive treatment with single agent belantamab mafodotin.

Group III: Part 1: Dose escalation of belantamab monotherapy Experimental Treatment 1 Intervention

Belantamab will be administered in participants with RRMM until progressive disease (PD)

Belantamab is already approved in United States, European Union for the following indications:

Approved in United States as Blenrep for:

• Relapsed or refractory multiple myeloma in adults

Approved in European Union as Blenrep for:

• Relapsed or refractory multiple myeloma in adults

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10543185/

Real-world study of the efficacy and safety of belantamab ... At 12±3 weeks, ORR was 35.6 % (26/73), including five patients (6.8%) with a complete response (CR), seven (9.6%) with a very good partial response (VGPR), and ...

2. nature.com nature.com/articles/s41408-025-01226-8

A real-world experience of efficacy and safety ... In summary, belantamab mafodotin appeared safe and relatively effective in this real-world heavily pretreated RRMM population, where the ...

3. gsk.com gsk.com/en-gb/media/press-releases/blenrep-shows-significant-overall-survival-benefit-reducing-the-risk-of-death-by-42-in-multiple-myeloma-at-or-after-first-relapse/

Blenrep shows significant overall survival benefit, reducing ... The analysis presented today shows a statistically significant 42% reduction in the risk of death among patients receiving the belantamab mafodotin combination.

4. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/4751/533572/Final-Results-of-Phase-1-Clinical-Trial-of

Final Results of Phase 1 Clinical Trial of Belantamab ... In the DREAMM-7 study, Belamaf showed superior efficacy outcomes compared to daratumumab when combined with bortezomib and dexamethasone.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2152265025001387

Treatment Patterns, Efficacy, and Tolerability of ... At 13-month follow-up, overall response rate (ORR) was 32%, median progression-free survival (PFS) 2.8 months, median duration of response (DOR) 11.0 months, ...

6. gsk.com gsk.com/en-gb/media/press-releases/gsk-provides-update-on-us-fda-advisory-committee-review-of-blenrep-belantamab-mafodotin-blmf-combinations-for-patients-with-relapsedrefractory-multiple-myeloma/

GSK provides update on US FDA advisory committee ... DREAMM-7 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin combined ...

7. myeloma.org myeloma.org/blog/blenrep-belantamab-mafodotin-for-multiple-myeloma

Blenrep for Myeloma: Uses, Side Effects & Status Learn about Blenrep (belantamab mafodotin), a treatment for multiple myeloma. This guide covers how it works, side effects, and its current ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352302625001632

Patient-reported outcomes with belantamab mafodotin ... Belantamab mafodotin demonstrated a significant progression-free survival benefit compared with daratumumab (HR 0·41, 95% CI 0·31–0·53; p<0·001) ...

9. ashpublications.org ashpublications.org/bloodneoplasia/article/2/3/100103/536762/Belantamab-mafodotin-in-patients-with-relapsed

Belantamab mafodotin in patients with relapsed/refractory ... Belantamab mafodotin showed ORR 45%, PFS 3.8 months, and OS 17.2 months in relapsed/refractory multiple myeloma in a real-world setting. ORR was ...