Belantamab Mafodotin + Lenalidomide + Dexamethasone for Multiple Myeloma

(DREAMM-10 Trial)

Recruiting at 87 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Disqualifiers: Amyloidosis, Waldenstrom's, POEMS, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 7 years

520 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment combination can help people with multiple myeloma, a type of blood cancer, live longer without disease progression. It tests two groups: one receiving belantamab mafodotin (an antibody-drug conjugate) with lenalidomide and dexamethasone, and the other receiving daratumumab with the same two drugs. Individuals recently diagnosed with multiple myeloma who are not candidates for a stem cell transplant might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

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

Earlier studies combining belantamab mafodotin with lenalidomide and dexamethasone revealed some safety concerns. Research found that serious side effects occurred in about 53% of patients, with rare cases being severe and one linked to the treatment. However, these results stem from early testing stages, which often aim to determine the safest dose.

Daratumumab, in contrast, has been used for a while and is approved for other treatments, with its safety generally well understood. Overall, the combination of these treatments appears promising, but potential risks must be considered. Prospective participants should consult their healthcare provider to understand the implications of joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for multiple myeloma because they offer innovative approaches to tackling the disease. Belantamab mafodotin is unique because it’s an antibody-drug conjugate, which means it combines a targeted antibody with a powerful anti-cancer agent, directly delivering the drug to cancer cells while sparing healthy ones. This targeted approach could potentially result in fewer side effects compared to traditional chemotherapy. On the other hand, daratumumab works by targeting a protein called CD38 on myeloma cells, enhancing the immune system's ability to fight the cancer. These mechanisms provide promising alternatives to the standard treatments like bortezomib and carfilzomib, opening new avenues for patients who might not respond well to existing therapies.

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

In this trial, participants will receive either Belantamab Mafodotin or Daratumumab, each combined with lenalidomide and dexamethasone. Studies have shown that Belantamab Mafodotin, when used with other drugs, effectively treats multiple myeloma, a type of blood cancer. The DREAMM-7 study found that Belantamab Mafodotin outperformed Daratumumab when combined with bortezomib and dexamethasone. Other research also supports its effectiveness, especially for patients who have tried many other treatments. Conversely, Daratumumab, also tested in this trial, is a well-known treatment for multiple myeloma. It has improved outcomes when used with medications like lenalidomide and dexamethasone. Both treatments help control the disease and improve patients' quality of life. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with newly diagnosed Multiple Myeloma who can't have a stem cell transplant. They must be able to consent, need treatment per IMWG criteria, and show specific levels of M-protein or free light chains in tests. Participants should be fairly active (ECOG 0-2) and have good organ function. Men must follow local contraception rules.

Inclusion Criteria

My tests show high levels of certain proteins indicating my condition.

I can sign and follow the study's consent form and rules.

I have newly diagnosed multiple myeloma needing treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Belantamab Mafodotin + Lenalidomide + Dexamethasone or Daratumumab + Lenalidomide + Dexamethasone until progressive disease, death, unacceptable toxicity, withdrawal of consent, or end of study

Up to approximately 7 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Belantamab Mafodotin
• Daratumumab

Trial Overview The study compares two treatments: BRd (Belantamab Mafodotin with Lenalidomide and Dexamethasone) versus DRd (Daratumumab with Lenalidomide and Dexamethasone). It's checking if BRd extends the time patients live without their disease getting worse or helps more patients reach no detectable cancer status.

How Is the Trial Designed?

Group I: Arm A: Belantamab Mafodotin + Lenalidomide + Dexamethasone Experimental Treatment 3 Interventions

Belantamab mafodotin, lenalidomide, and dexamethasone will be administered. Treatment will continue in both arms until progressive disease (PD), death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.

Group II: Arm B: Daratumumab + Lenalidomide + Dexamethasone Active Control 3 Interventions

Daratumumab, lenalidomide, and dexamethasone will be administered. Treatment will continue in both arms until PD, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.

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. 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.

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

Treatment Patterns, Efficacy, and Tolerability of ... The efficacy and safety profile of 2.5 mg/kg was favorable compared to 3.4 mg/kg.9 Subsequently, the DREAMM-3 trial compared belantamab mafodotin to ...

4. haematologica.org haematologica.org/article/view/haematol.2022.281772

Real-world study of the efficacy and safety of belantamab ... Belantamab mafodotin proved effective in the phase II DREAMM-2 trial. Based on the data from this trial, a temporary utilization program (ATU ...

5. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2403407

Belantamab Mafodotin, Pomalidomide, and ... At a median follow-up of 21.8 months (range, <0.1 to 39.2), the 12-month estimated progression-free survival with BPd was 71% (95% confidence ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.7512

Belantamab mafodotin plus lenalidomide/dexamethasone ... We report the long-term safety & efficacy results of a novel, extended dosing schedule of belantamab mafodotin (belamaf) combined with Lenalidomide & ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38356458/

Belantamab mafodotin, lenalidomide and dexamethasone ... Overall, the rates of very good partial response and better and complete response and better were 83.3% and 52.8%, respectively, without ...

8. nature.com nature.com/articles/s41408-024-01155-y

Results from Arm A of Phase 1/2 DREAMM-6 trial SAEs were reported in 53% of patients (Table 1). SAEs were fatal in four patients, with one (febrile neutropenia) deemed related to belantamab ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123113668

Long-Term Safety and Efficacy Results of Belantamab ... Part 1 evaluates the safety/tolerability of three belamaf doses (2.5/1.9/1.4 mg/kg) plus Rd in 36 pts and establishes the recommended phase 2 dose (RP2D).