Belantamab Mafodotin for Lymphoma

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Jacob D. Soumerai, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Jacob Soumerai, MD

Must not be taking: Investigational agents

Disqualifiers: Corneal disease, CNS involvement, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

In this research study is looking to see how safe and effective belantamab mafodotin is in relapsed or refractory plasmablastic lymphoma or ALK+ large B-cell lymphoma. * This research study involves the study drug belantamab mafodotin. * Belantamab mafodotin is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a drug. It works by using the antibody portion to enter into the lymphoma cells, and then releasing the drug portion to kill the lymphoma cells.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have used an investigational drug or approved systemic lymphoma therapy within 14 days before the first dose of the study drug, except for steroids, which are allowed.

Is Belantamab Mafodotin safe for humans?

Belantamab Mafodotin has been shown to have manageable safety in patients with multiple myeloma, but it can cause significant eye-related side effects like keratopathy (damage to the cornea), blurred vision, and dry eyes. It also has a risk of causing low platelet counts (thrombocytopenia) and infections, and is available only through a restricted program due to these risks. ^{1 2 3 4 5}

What makes the drug Belantamab Mafodotin unique for treating lymphoma?

Belantamab Mafodotin is unique because it is a first-in-class antibody-drug conjugate that targets B-cell maturation antigen (BCMA) on cancer cells, delivering a powerful cell-killing agent directly to the tumor. This targeted approach is different from traditional chemotherapy, which affects both healthy and cancerous cells. ^{1 2 3 6 7}

Research Team

Jacob D. Soumerai, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Adults with relapsed or refractory plasmablastic lymphoma or ALK+ large B-cell lymphoma who have measurable disease and have previously undergone systemic lymphoma therapy. Participants must be in relatively good health (ECOG ≤2), not pregnant, using contraception, able to consent, and without serious concurrent illnesses or recent treatments that could interfere.

Inclusion Criteria

I have a tumor that can be measured and is at least 10mm or 15mm big depending on its location.

I don't have any other cancer affecting my current treatment.

Your platelet count must be at least 50,000 per microliter.

Exclusion Criteria

I have a mild eye surface condition.

I have no major side effects from previous cancer treatments.

I do not have any uncontrolled illnesses or active infections.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive belantamab mafodotin intravenously on day 1 of a 21-day cycle until progression or intolerance

Up to 2 years

Every 21 days (outpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Every 6 months

Treatment Details

Interventions

• Belantamab Mafodotin (Antibody-drug conjugate)

Trial Overview The trial is testing the safety and effectiveness of belantamab mafodotin, an antibody-drug conjugate designed to target and kill lymphoma cells. It's for patients whose cancer has returned after treatment or didn't respond to previous therapies.

Participant Groups

Group I: (BELANTAMAB MAFODOTIN Experimental Treatment 1 Intervention

* Belantamab mafodotin will be administered intravenously on day 1 of a 21-day cycle. * Treatment is intended to be administered on an outpatient basis.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Moores Cancer Center at UC San Diego Health La Jolla, CA

Memorial Sloan Kettering Cancer Center New York, NY

Massachusetts General Hospital Boston, MA

MD Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

Jacob Soumerai, MD

Lead Sponsor

Trials

2

Patients Recruited

30+

GlaxoSmithKline

Industry Sponsor

Trials

4834

Patients 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)

Findings from Research

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) 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 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 (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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Exposure-Response Analyses for Therapeutic Dose Selection of Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma. [2022]

2. 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]

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

Belantamab Mafodotin: First Approval. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Real-world experience with belantamab mafodotin therapy for relapsed/refractory multiple myeloma: A multicentre retrospective study. [2023]

6. 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]

7. 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]