Belantamab Mafodotin vs. Daratumumab for Multiple Myeloma

(DREAMM 7 Trial)

Not currently recruiting at 212 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Must not be taking: Anti-CD38, Anti-BCMA

Disqualifiers: Peripheral neuropathy, Stem cell transplant, 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 73 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for individuals with multiple myeloma, a type of blood cancer that has returned after previous treatment. One group will receive belantamab mafodotin (an antibody-drug conjugate) with bortezomib and dexamethasone, while the other group will receive daratumumab with the same combination. The trial aims to determine which treatment is safer and more effective. Individuals previously treated for multiple myeloma who show signs of the disease returning might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants early access to potentially effective treatments.

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 coordinators or your doctor.

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

Research has shown that belantamab mafodotin is generally well-tolerated by patients with relapsed multiple myeloma. Studies have found that it can cause side effects, such as vision changes and low blood counts, but these are usually manageable with medical help. The FDA has approved belantamab mafodotin for treating relapsed multiple myeloma, indicating that its safety is considered acceptable.

Research indicates that daratumumab is also well-tolerated. This medication has been successfully used to treat multiple myeloma. Common side effects include tiredness and nausea, but they are usually mild and manageable.

Both treatments have been extensively studied and have shown a good safety record in real-world use. For those considering joining a trial, these findings suggest that both treatments have side effects that most people can manage. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about belantamab mafodotin for multiple myeloma because it targets cancer cells in a unique way. Unlike most treatments that aim to suppress the immune system, belantamab mafodotin uses an antibody-drug conjugate to deliver a toxic payload directly to myeloma cells, potentially reducing harm to healthy cells. This precise targeting helps to minimize side effects, offering a promising alternative to traditional therapies like chemotherapy. Meanwhile, daratumumab, another treatment being compared, works by leveraging the body's immune system to attack myeloma cells, which is different from how belantamab mafodotin operates. These innovative mechanisms give hope for more effective and less toxic treatment options for patients with multiple myeloma.

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

Research shows that belantamab mafodotin, one of the treatments in this trial, may be promising for treating multiple myeloma. One study found it lowered the risk of death by 42% in patients whose cancer had returned, suggesting its effectiveness. Additionally, real-world data showed that about 36% of patients responded to the treatment, with some experiencing complete or very good partial improvements. In this trial, participants in one arm will receive belantamab mafodotin combined with bortezomib and dexamethasone.

Conversely, daratumumab, another treatment option in this trial, is already a well-known treatment for multiple myeloma when used with other drugs. It has been proven to help control the disease and improve patient outcomes. Participants in the other arm of this trial will receive daratumumab combined with bortezomib and dexamethasone. This trial compares both treatments to determine which might work better for people whose multiple myeloma has returned. ^{2 3 6 7 8}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

This trial is for people with multiple myeloma who've had at least one prior treatment and whose disease has gotten worse after their most recent therapy. They must have good organ function, a performance status showing they can handle daily activities, and measurable signs of the disease. People with eye diseases affecting the cornea, intolerance to certain drugs used in this study, ongoing severe nerve pain or damage, previous treatments targeting BCMA or an allogenic stem cell transplant cannot join.

Inclusion Criteria

All my previous cancer treatment side effects are mild, except for hair loss.

My organs are working well.

I have been diagnosed with multiple myeloma according to IMWG standards.

Exclusion Criteria

I can't tolerate bortezomib or my condition worsened on it.

My condition worsened during or within 2 months after anti-CD38 therapy.

I have had a stem cell transplant from a donor.

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 with bortezomib/dexamethasone or daratumumab with bortezomib/dexamethasone

Up to 73 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 41 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Belantamab Mafodotin
• Bortezomib
• Daratumumab
• Dexamethasone

Trial Overview The study compares two combinations of cancer drugs in patients with relapsed multiple myeloma: Belantamab Mafodotin with Bortezomib/Dexamethasone versus Daratumumab with Bortezomib/Dexamethasone. It's randomized and open-label so participants know which treatment they're getting.

How Is the Trial Designed?

Group I: Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A) Experimental Treatment 3 Interventions

Group II: Daratumumab and Bortezomib plus Dexamethasone (Arm B) Active Control 3 Interventions

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

Approved in European Union as Blenrep for:

• Relapsed or refractory multiple myeloma

Approved in United States as Blenrep for:

• Relapsed or refractory multiple myeloma

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

Published Research Related to This Trial

Belantamab mafodotin (belamaf) is an effective treatment for relapsed or refractory multiple myeloma, showing a 32% overall response rate in the phase II DREAMM-2 study with 95 patients.

While most patients experienced microcyst-like epithelial changes (MECs) as a side effect, these were generally manageable, with a high resolution rate and no permanent vision loss reported, indicating a need for careful monitoring and collaboration between eye care and oncology professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study. Farooq, AV., Degli Esposti, S., Popat, R., et al.[2020]

The budget impact analysis of belantamab mafodotin (belamaf) for patients with relapsed/refractory multiple myeloma indicates that its introduction would be budget neutral for a US health plan, with minimal cost changes over 3 years.

In a hypothetical health plan with 1 million members, only 33 patients were identified as eligible for treatment, and the analysis showed that the budget impact was most sensitive to treatment duration and drug acquisition costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Budget Impact of Belantamab Mafodotin (Belamaf) Adoption in the Treatment of Patients with Relapsed or Refractory Multiple Myeloma in the United States. Shah, A., Tosh, JC., Ambavane, A., et al.[2022]

In the DREAMM-2 study, after 13 months of follow-up, 32% of patients with relapsed or refractory multiple myeloma achieved an overall response to belantamab mafodotin (belamaf) at a dose of 2.5 mg/kg, indicating its efficacy in a heavily pretreated population.

The study found that belamaf maintained clinical activity without new safety concerns, even in patients experiencing prolonged dose delays due to corneal events, suggesting it is a safe treatment option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longer term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13-month follow-up from the pivotal DREAMM-2 study. Lonial, S., Lee, HC., Badros, A., et al.[2022]

Belantamab mafodotin is a first-in-class monoclonal antibody-drug conjugate designed to treat relapsed or refractory multiple myeloma by targeting B-cell maturation antigen (BCMA) and delivering a cytotoxic agent directly to cancer cells.

It received regulatory approval in the USA and EU in August 2020 based on promising results from the DREAMM-2 trial, specifically for patients who have undergone at least four prior therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belantamab Mafodotin: First Approval. Markham, A.[2021]

Belantamab mafodotin (belamaf) significantly improves overall survival (OS) and duration of response (DoR) in patients with relapsed/refractory multiple myeloma compared to selinexor plus low-dose dexamethasone, with a hazard ratio of 0.53 for OS and 0.41 for DoR, indicating its efficacy as a treatment option.

Belamaf also shows a favorable safety profile, with fewer severe adverse events compared to selinexor plus dexamethasone, making it a promising single-agent therapy for patients who have already undergone multiple lines of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DREAMM-2: Indirect Comparisons of Belantamab Mafodotin vs. Selinexor + Dexamethasone and Standard of Care Treatments in Relapsed/Refractory Multiple Myeloma. Prawitz, T., Popat, R., Suvannasankha, A., et al.[2022]

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. 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.

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

Belantamab Mafodotin shows significant overall survival ... Belantamab Mafodotin shows significant overall survival benefit, reducing the risk of death by 42% in multiple myeloma at or after first relapse.

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37078253/

Real-world study of the efficacy and safety of belantamab ... Overall, our data are concordant with the results from DREAMM-2 in terms of efficacy and safety on a non-biased population. Publication types.

7. gsk.com gsk.com/en-gb/media/press-releases/blenrep-approved-by-us-fda-for-use-in-treatment-of-relapsedrefractory-multiple-myeloma/

Blenrep approved by US FDA for use in treatment of ... Significant unmet need for patients requires new and novel treatments1; DREAMM-7 showed a 51% reduction in the risk of death and tripled ...

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

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