62 Participants Needed

Belantamab Mafodotin for Multiple Myeloma

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial tests alternate doses and dosing schedules of belantamab mafodotin in treating patients with triple-class multiple myeloma that has come back (after a period of improvement) (recurrent) and/or does not respond to treatment (or that has not responded to previous treatment) (refractory). Belantamab mafodotin is a monoclonal antibody, belantamab, linked to a chemotherapy drug, mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as BCMA receptors, and delivers mafodotin to kill them. This trial may help researchers determine if alternate doses and dosing schedules work better in preventing certain side effects, such as eye toxicity, and treating patients with recurrent or refractory multiple myeloma.

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

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that certain medications, like systemic corticosteroids, are allowed in emergency situations. It's best to discuss your specific medications with the trial team.

What is the safety profile of Belantamab Mafodotin in humans?

Belantamab Mafodotin has been associated with eye-related side effects, such as changes in vision and dry eyes, which are common and can be severe. Other side effects include low platelet counts (thrombocytopenia) and infections. The treatment is only available through a special program due to these safety concerns.12345

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 that targets BCMA (B-cell maturation antigen) on myeloma cells, delivering a powerful cancer-killing agent directly to the tumor. This drug is specifically used for patients with relapsed or refractory multiple myeloma who have already tried several other treatments.36789

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

Belantamab Mafodotin has shown effectiveness in treating multiple myeloma, with studies reporting an overall response rate of 31-34% in patients who have tried several other treatments. It was approved by the FDA based on these results, demonstrating its potential to help patients with relapsed or refractory multiple myeloma.12367

Who Is on the Research Team?

RD

Ricardo D. Parrondo, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Adults with multiple myeloma that's resistant to standard treatments, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies. Participants must have adequate organ function and not be pregnant or planning to become pregnant. They should not have certain other medical conditions like active infections or recent major surgery.

Inclusion Criteria

My diagnosis of multiple myeloma is confirmed by lab tests.
Your absolute neutrophil count is equal to or higher than 1.0 x 10^9 per liter.
Provide written informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol
See 15 more

Exclusion Criteria

I am currently being treated for an infection.
I am HIV positive.
My liver condition is stable.
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Patients receive belantamab mafodotin intravenously on day 1 of each cycle. Cycles repeat every 3 to 6 weeks depending on the group, in the absence of disease progression or unacceptable toxicity.

Variable (3 to 6 weeks per cycle)
1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 12 weeks for up to 5 years.

Up to 5 years
Every 12 weeks (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Belantamab Mafodotin
Trial Overview The trial is testing different doses and schedules of Belantamab Mafodotin for relapsed/refractory multiple myeloma. This drug targets cancer cells by attaching to BCMA receptors on their surface and delivering a chemotherapy agent directly to them.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (low dose and high dose belantamab mafodotin)Experimental Treatment7 Interventions
Group II: Group I (low dose belantamab mafodotin)Active Control7 Interventions

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

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Approved in European Union as Blenrep for:
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Approved in United States as Blenrep for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Published Research Related to This Trial

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

Citations

DREAMM-2: Indirect Comparisons of Belantamab Mafodotin vs. Selinexor + Dexamethasone and Standard of Care Treatments in Relapsed/Refractory Multiple Myeloma. [2022]
Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study. [2020]
Belantamab Mafodotin: First Approval. [2021]
FDA Approval Summary: Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma. [2023]
Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma: Results of the Compassionate Use or the Expanded Access Program in Spain. [2023]
Exposure-Response Analyses for Therapeutic Dose Selection of Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma. [2022]
Real-world experience with belantamab mafodotin therapy for relapsed/refractory multiple myeloma: A multicentre retrospective study. [2023]
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]
Belantamab mafodotin in combination with novel agents in relapsed/refractory multiple myeloma: DREAMM-5 study design. [2021]
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