Belantamab Mafodotin for Multiple Myeloma

Overseen By Neeraj Saini, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Investigational drugs, Systemic steroids

Disqualifiers: Corneal disease, Neuropathy, Liver disease, Renal condition, Cardiovascular risk, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether belantamab mafodotin, an anti-cancer drug, can prevent multiple myeloma from returning after a stem cell transplant. Researchers aim to determine if the drug is safe for patients who have undergone this procedure. Individuals whose multiple myeloma has returned or not responded to treatment and who have had a stem cell transplant might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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 use an investigational drug or approved systemic anti-myeloma therapy, including systemic steroids, within 14 days before the first dose of the study drug.

Is there any evidence suggesting that belantamab mafodotin is likely to be safe for humans?

Research has shown that belantamab mafodotin, also known as Blenrep, received FDA approval to treat relapsed or refractory multiple myeloma. This approval indicates that it has been tested for safety in specific situations and has shown positive results. However, important side effects exist. Studies have found that many patients experience eye problems, known as ocular toxicity. In some cases, these issues significantly affected over 70% of patients repeatedly. Potential participants must discuss these risks with their doctors to understand how they might be personally affected. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about belantamab mafodotin for multiple myeloma because it offers a new approach to tackling this cancer. Unlike traditional treatments that typically target proteins on cancer cells or use chemotherapy, belantamab mafodotin is an antibody-drug conjugate that specifically targets the B-cell maturation antigen (BCMA) on multiple myeloma cells. This targeted mechanism allows for the delivery of a potent anti-cancer agent directly to the cancer cells, potentially reducing the impact on healthy cells and leading to fewer side effects. Additionally, its administration every eight weeks could offer more convenience compared to standard therapies that require more frequent dosing.

What evidence suggests that belantamab mafodotin might be an effective treatment for multiple myeloma?

Research has shown that belantamab mafodotin, the treatment under study in this trial, may help treat multiple myeloma, a type of blood cancer. Studies found that 68.4% of patients with relapsed or hard-to-treat multiple myeloma responded to the treatment, meaning their cancer shrank or disappeared. In another study, patients went an average of 8.1 months without their disease worsening. This treatment targets a protein called BCMA on multiple myeloma cells, helping the drug attack the cancer more effectively. Overall, belantamab mafodotin appears to be a promising option for managing multiple myeloma. ^{6 7 8 9 10}

Who Is on the Research Team?

Neeraj Saini, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with relapsed/refractory multiple myeloma after at least two prior treatments, including specific standard agents. Participants must have a partial response or better to previous therapies, adequate blood counts and organ function, and no history of certain other diseases or recent monoclonal antibody treatment.

Inclusion Criteria

Platelet count ≥ 50,000/mm3, Hemoglobin ≥ 8 g/dL, ANC ≥ 1.0 × 109/L

Not pregnant or lactating

I have undergone at least two treatments with specific medications.

Exclusion Criteria

Presence of hepatitis B or C

Use of contact lenses during the study

My liver condition is stable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Belantamab mafodotin is administered by vein over 30 minutes every 8 weeks as maintenance therapy starting approximately 3 months post salvage auto-transplant

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including progression-free survival and overall survival assessed up to 2 years

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Belantamab mafodotin

Trial Overview The study tests if Belantamab Mafadotin (Blenrep) can prevent the return of multiple myeloma after an autologous stem cell transplant. It also examines the drug's safety post-transplant in patients who've had this type of therapy before or are undergoing it for the first time.

How Is the Trial Designed?

Group I: Belantamab mafodotin Experimental Treatment 1 Intervention

belantamab mafodotin by vein over 30 minutes every 8 weeks

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

In the DREAMM-2 study involving 196 patients with relapsed or refractory multiple myeloma, belantamab mafodotin demonstrated anti-myeloma activity, with overall response rates of 31% in the 2.5 mg/kg cohort and 34% in the 3.4 mg/kg cohort.

The treatment had a manageable safety profile, with common grade 3-4 adverse events including keratopathy and thrombocytopenia, and only two treatment-related deaths, indicating that while there are risks, the benefits may outweigh them for patients with limited options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lonial, S., Lee, HC., Badros, A., et al.[2020]

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, an antibody-drug conjugate, has shown significant efficacy and manageable safety in treating heavily pretreated relapsed/refractory multiple myeloma, as demonstrated in the phase I DREAMM-1 and phase II DREAMM-2 studies.

The recommended dose of belantamab mafodotin is 2.5 mg/kg every 3 weeks, with safety outcomes like corneal events and thrombocytopenia being closely linked to drug exposure, highlighting the importance of monitoring patient characteristics and disease burden in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure-Response Analyses for Therapeutic Dose Selection of Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma. Ferron-Brady, G., Rathi, C., Collins, J., et al.[2022]

Belantamab mafodotin (belamaf) is an approved treatment for adults with relapsed/refractory multiple myeloma, showing effectiveness by targeting BCMA and eliminating myeloma cells through multiple mechanisms.

The ongoing DREAMM-5 study is exploring the safety and efficacy of belamaf in combination with other novel therapies, which may enhance its anticancer effects compared to belamaf alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belantamab mafodotin in combination with novel agents in relapsed/refractory multiple myeloma: DREAMM-5 study design. Nooka, AK., Weisel, K., van de Donk, NW., et al.[2021]

Belantamab mafodotin (BLENREP) received accelerated FDA approval for treating relapsed or refractory multiple myeloma in adults who have undergone at least four prior therapies, showing an overall response rate of 31% to 34% in the DREAMM-2 trial with 2.5 or 3.4 mg/kg doses.

The most common side effect was keratopathy, affecting 71% to 77% of patients, leading to a boxed warning for ocular toxicity, indicating the need for careful monitoring and a restricted distribution program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma. Baines, AC., Ershler, R., Kanapuru, B., et al.[2023]

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]

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]

In a study of 106 heavily pretreated patients with relapsed/refractory multiple myeloma, belantamab mafodotin showed an overall response rate of 45.5% and a median overall survival of 14.5 months, indicating its efficacy in a real-world setting.

The treatment was associated with significant adverse effects, particularly ocular toxicity (68.4% experienced keratopathy), but the overall toxicity profile was considered tolerable, suggesting that the benefits may outweigh the risks for many patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world experience with belantamab mafodotin therapy for relapsed/refractory multiple myeloma: A multicentre retrospective study. Shragai, T., Magen, H., Lavi, N., et al.[2023]

In a real-world study of 106 patients with relapsed or refractory multiple myeloma, belantamab mafodotin (BM) demonstrated an overall response rate of 38.1% and a median overall survival of 9.3 months, indicating its efficacy as a treatment option for heavily pre-treated patients.

The treatment was associated with significant safety concerns, particularly ophthalmic adverse events, with 48% of patients experiencing eye-related issues, including keratopathy in 37.5% of cases, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world study of the efficacy and safety of belantamab mafodotin (GSK2857916) in relapsed or refractory multiple myeloma based on data from the nominative ATU in France: the IFM 2020-04 study. Talbot, A., Bobin, A., Tabone, L., et al.[2023]

Citations

1. 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 ...

2. ashpublications.org ashpublications.org/bloodadvances/article/9/9/2155/535577/Prior-exposure-to-belantamab-mafodotin-influences

Prior exposure to belantamab mafodotin influences outcomes ... The median progression-free survival (PFS) with belantamab was 8.1 months, and the median time from the last dose of belantamab to ide-cel was ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e19512

Targeting BCMA in relapsed and refractory multiple myeloma Efficacy analysis revealed that the pooled ORR was 68.4% (95% CI: 61.2–75.6), with ≥very good partial response achieved in 65.2% (95% CI: 57.4– ...

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

Treatment Patterns, Efficacy, and Tolerability of ... This single-site, retrospective study examined 30 adults with multiple myeloma receiving care at Duke Cancer Institute who began belantamab mafodotin ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11631777/

The Antibody Drug Conjugate, Belantamab-Mafodotin, in ... The results regarding efficacy and safety in the second phase appear in Table 1. A dose of 3.4 mg/kg had significant activity in patients with ...

6. 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 ... Interim efficacy and safety data for Blenrep as a first line treatment are expected in early 2028 with enrolment expanded to US sites to ...

7. fda.gov fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma

FDA approves belantamab mafodotin-blmf for relapsed or ... On October 23, 2025, the Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), a B-cell maturation ...

8. cancertherapyadvisor.com cancertherapyadvisor.com/news/fda-approves-blenrep-for-relapsed-or-refractory-multiple-myeloma/

FDA Approves Blenrep for Relapsed or Refractory Multiple ... Triplet combination treatment shows 51 percent reduction in the risk for death and tripled median progression-free survival versus a ...

9. onclive.com onclive.com/view/fda-approves-belantamab-mafodotin-plus-bortezomib-and-dexamethasone-for-r-r-multiple-myeloma

FDA Approves Belantamab Mafodotin Plus Bortezomib and ... The FDA approved BVd for relapsed/refractory multiple myeloma after at least two prior therapies, based on DREAMM-7 trial results.

10. cancernetwork.com cancernetwork.com/view/fda-approves-belantamab-mafodotin-in-r-r-multiple-myeloma

FDA Approves Belantamab Mafodotin in R/R Multiple ... Recurrent ocular toxicity events occurred in 70% and 72%, with a median of 3 grade 2 or higher KVA events; 58% and 57% of patients had ongoing ...