Belantamab Mafodotin vs. Daratumumab for Multiple Myeloma

(DREAMM 7 Trial)

Recruiting at 181 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

494 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.

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.

What data supports the effectiveness of the drug Belantamab Mafodotin for treating multiple myeloma?

Research shows that Belantamab Mafodotin, used alone, had a 32% overall response rate in patients with multiple myeloma who had already tried several other treatments. This means about one-third of these patients saw a significant improvement in their condition. ^{1 2 3 4 5}

What makes the drug Belantamab Mafodotin unique for treating multiple myeloma?

Belantamab Mafodotin is unique because it is a first-in-class antibody-drug conjugate (ADC) that targets B-cell maturation antigen (BCMA) on myeloma cells, delivering a cytotoxic agent directly to the cancer cells. This approach is particularly promising for patients with relapsed or refractory multiple myeloma who have already undergone multiple treatments. ^{1 2 3 6 7}

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

1. United States 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. [2022]

2. England 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. [2020]

3. New Zealand 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

EMA Review of Belantamab Mafodotin (Blenrep) for the Treatment of Adult Patients with Relapsed/Refractory Multiple Myeloma. [2022]

5. United States 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. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Belantamab Mafodotin: First Approval. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Belantamab mafodotin for relapsed or refractory multiple myeloma. [2022]