Belantamab Mafodotin for Multiple Myeloma

(DREAMM 13 Trial)

No longer recruiting at 25 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: GlaxoSmithKline

Must not be taking: Antivirals, Antiretrovirals

Disqualifiers: Active infections, 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: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of belantamab mafodotin, an antibody-drug conjugate, for individuals with multiple myeloma—a type of blood cancer—who have exhausted other treatments. The trial aims to assess the drug's behavior in the body, along with its safety and tolerability, particularly in participants with varying liver function levels. Different groups in the trial include those with normal liver function and those with moderate or severe liver issues. Participants should have multiple myeloma that has returned or not responded to treatment and should be aware of any liver conditions. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new drug.

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 belantamab mafodotin is likely to be safe for humans?

Research has shown that belantamab mafodotin has been tested in people with relapsed or refractory multiple myeloma, a type of blood cancer. In earlier studies, 218 patients received this treatment, and about 24% continued treatment for six months or more.

This treatment has demonstrated some ability to fight multiple myeloma. However, like many treatments, it can cause side effects. Some patients experienced vision changes and low blood cell counts. These side effects were usually managed by adjusting the dose or taking breaks from the treatment.

The FDA has already approved belantamab mafodotin for treating relapsed or refractory multiple myeloma, indicating it meets certain safety standards for this condition. However, since this trial is in its early phase, researchers are still studying the treatment's safety in people with different liver functions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple myeloma?

Belantamab mafodotin is unique because it targets a specific protein called BCMA, which is found on multiple myeloma cells. Unlike standard treatments like proteasome inhibitors or immunomodulatory drugs, belantamab mafodotin uses an antibody-drug conjugate to deliver a potent chemotherapy agent directly to the cancer cells, minimizing damage to healthy cells. This targeted approach not only aims to enhance effectiveness but also reduces the typical side effects associated with traditional chemotherapy. Researchers are excited because this method could potentially provide a more precise treatment with fewer long-term impacts on patients’ overall health.

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

Research has shown that belantamab mafodotin effectively treats multiple myeloma that has returned or is unresponsive to other treatments. One study found it reduced the risk of death by 51% for patients using this drug. Real-world experiences have confirmed these results, indicating patient benefits. Other studies have demonstrated its safety and efficacy, offering hope for those with this challenging condition. Overall, the evidence suggests that belantamab mafodotin can be a valuable treatment for multiple myeloma patients with limited options. Participants in this trial will receive belantamab mafodotin, with groups stratified by hepatic function to assess its safety and efficacy across different levels of liver impairment. ^{4 6 7 8 9}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

Adults with Multiple Myeloma who've had at least one prior treatment can join this trial. They must have a certain level of organ function and be able to consent. Women and men must use contraception, and those with previous stem cell transplants or specific viral exposures may qualify under conditions.

Inclusion Criteria

My organs are functioning well.

You can join the study if you have had a certain type of stem cell transplant in the past.

I am using approved methods of contraception.

Exclusion Criteria

I have specific blood, nerve, or skin conditions related to my cancer.

You have HIV under certain conditions.

I have not received belantamab mafodotin therapy in the last 90 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Belantamab mafodotin monotherapy to assess pharmacokinetics, safety, and tolerability

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Belantamab Mafodotin

Trial Overview

The study is testing Belantamab Mafodotin's effects on patients with different liver functions. It aims to understand how the drug moves in the body, its safety, and tolerability in those with normal liver function versus those with impairments.

How Is the Trial Designed?

Group I: Part 2,Group 3: Participants with severe hepatic impairment Experimental Treatment 1 Intervention

Participants with severe hepatic impairment (Serum bilirubin \>3 times ULN and any AST) will be administered with Belantamab mafodotin

Group II: Part 1, Group 2: Participants with moderate hepatic impairment Experimental Treatment 1 Intervention

Participants with moderate hepatic impairment (Serum bilirubin greater than \>1.5 - 3 times ULN and any AST) will be administered with Belantamab mafodotin

Group III: Part 1, Group 1: Participants with normal hepatic function Experimental Treatment 1 Intervention

Participants with normal hepatic function (Serum bilirubin and Aspartate aminotransferase \[AST\] less than or equal to \[\<=\] Upper limit of normal \[ULN\]) will be administered with Belantamab mafodotin

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) 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]

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]

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]

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 (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]

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 (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 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]

In a study of 156 patients with relapsed and refractory multiple myeloma, belantamab-mafodotin (belamaf) demonstrated an overall response rate of 41.8%, with significant improvements in progression-free survival for those achieving at least minimal response (MR).

The safety profile of belamaf was manageable, with corneal events being the most common adverse effects, affecting 87.9% of patients, though only 1.3% discontinued treatment due to ocular toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma: Results of the Compassionate Use or the Expanded Access Program in Spain. de la Rubia, J., Alonso, R., Clavero, ME., et al.[2023]

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]

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