200 Participants NeededMy employer runs this trial

Belantamab Mafodotin + Standard Care for Multiple Myeloma

Recruiting at 49 trial locations
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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial targets individuals with multiple myeloma, a type of blood cancer, that has returned or isn't responding to current treatments. It aims to determine if belantamab mafodotin (an antibody-drug conjugate), administered less frequently with other cancer medicines, can effectively combat the cancer while reducing eye-related side effects. The study includes different groups receiving belantamab mafodotin in combination with either pomalidomide, bortezomib, or carfilzomib, alongside dexamethasone. Those previously treated for multiple myeloma but still experiencing disease progression might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants, offering a chance to contribute to significant findings in cancer treatment.

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

The trial requires that you stop any systemic anti-myeloma therapy, including chemotherapy and systemic steroids, at least 30 days before starting the study treatment. If you are on any other medications, the protocol does not specify, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found the combination of belantamab mafodotin with pomalidomide and dexamethasone to be generally safe. Most patients tolerated the treatment well, with only a few experiencing serious side effects. However, like many cancer treatments, some patients experienced side effects such as low blood platelet count (thrombocytopenia) and low red blood cell count (anemia).

Research on the combination of belantamab mafodotin with bortezomib and dexamethasone showed that while some serious side effects occurred, many patients still managed the treatment well. Most side effects were manageable, and only a few were severe.

The combination of belantamab mafodotin with carfilzomib and dexamethasone also demonstrated promising safety results. In these studies, most patients experienced mild to moderate side effects, and serious issues were less common.

Overall, these combinations have shown to be reasonably safe. However, it's important to know that some side effects, especially those affecting blood cells, can occur. Always discuss potential risks with your doctor before joining a trial.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Belantamab Mafodotin for multiple myeloma because it employs a novel mechanism of action compared to current treatments like lenalidomide, bortezomib, and dexamethasone. Unlike these standard therapies, Belantamab Mafodotin is an antibody-drug conjugate that specifically targets and delivers a potent anti-cancer agent directly to the cancer cells, potentially enhancing its effectiveness while minimizing damage to healthy cells. This targeted approach could offer a more precise and powerful option for patients, especially when combined with other medications like pomalidomide, bortezomib, or carfilzomib, as explored in the trial.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

This trial will evaluate the effectiveness of belantamab mafodotin combined with different standard care regimens for multiple myeloma. Research has shown that belantamab mafodotin, when used with pomalidomide and dexamethasone, yields promising results for treating multiple myeloma. Specifically, one study found that 71% of patients experienced no cancer worsening over a year. Another study demonstrated that this combination helps control cancer for a longer duration. In this trial, one arm will test belantamab mafodotin with pomalidomide and dexamethasone. Another arm will test belantamab mafodotin combined with bortezomib and dexamethasone, which studies indicate provide significant benefits in both controlling cancer and improving survival rates. The combination with carfilzomib and dexamethasone, tested in a separate arm, showed an 83% overall response rate, indicating a strong cancer-fighting effect. Overall, these combinations suggest that belantamab mafodotin could effectively manage relapsed or resistant multiple myeloma.678910

Are You a Good Fit for This Trial?

This trial is for adults (18+) with multiple myeloma that has come back or isn't responding to treatment. Participants must have had 1-2 prior treatments, be in generally good health, and meet certain lab criteria. People with serious heart, kidney, liver issues, active infections like hepatitis B/C or HIV, recent major surgery, or eye problems can't join.

Inclusion Criteria

I have taken lenalidomide for at least 2 cycles in a previous treatment.
I have at least one tumor or lesion that can be measured.
Participants must meet contraceptive requirements as per local regulations
See 8 more

Exclusion Criteria

I have not taken pomalidomide before and am not intolerant to it.
I do not have active plasma cell leukemia.
I have not had any other invasive cancers besides multiple myeloma under allowed conditions.
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive belantamab mafodotin in combination with standard of care regimens for relapsed-refractory multiple myeloma

52 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Belantamab Mafodotin

Trial Overview

The study tests belantamab mafodotin given less often along with standard cancer drugs (carfilzomib or bortezomib plus dexamethasone or pomalidomide) for relapsed/refractory multiple myeloma. It compares effectiveness and safety of these combinations.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Belantamab mafodotin + Pomalidomide + Dexamethasone (BPd)Experimental Treatment3 Interventions
Group II: Belantamab mafodotin + Carfilzomib + dexamethasone (BKd)Experimental Treatment3 Interventions
Group III: Belantamab mafodotin + Bortezomib + Dexamethasone (BVd)Experimental Treatment3 Interventions

Find a Clinic Near You

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 profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40680752/

Patient-reported outcomes with belantamab mafodotin, ...

Belantamab mafodotin, bortezomib, and dexamethasone showed significant progression-free survival benefit compared with daratumumab, bortezomib, and ...

Belantamab Mafodotin, Bortezomib, and Dexamethasone ...

Multiple studies in this relapsed/refractory MM population have shown progression-free survival (PFS) benefit; however, it is important that this translates ...

Belantamab Mafodotin Combo Could Be New SOC for ...

BVd significantly improved overall survival and response rates compared to DVd in relapsed/refractory multiple myeloma patients. The BVd regimen ...

Second-Line Belantamab Mafodotin in Multiple Myeloma

Both the DREAMM-7 and DREAMM-8 trials demonstrated significant PFS benefit with belantamab in combination with bortezomib and dexamethasone (Bela-Vd) or in ...

Belantamab Mafodotin, Bortezomib, and Dexamethasone ...

Vania Hungria presents the Phase 3 DREAMM-7 trial results, demonstrating that belantamab mafodotin, bortezomib, and dexamethasone (BVd) achieved ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40680754/

Belantamab mafodotin plus bortezomib and ...

The primary endpoint was progression-free survival; key secondary endpoints were overall survival, minimal residual disease negativity in ...

Efficacy and Safety of Belantamab Mafodotin with Bortezomib ...

Twenty-eight (26%) patients experienced any study treatment-related SAEs; 3 of 7 fatal SAEs had a treatment-related primary cause. The ORR was ...

Belantamab Mafodotin, Bortezomib, and Dexamethasone ...

Belantamab mafodotin had single-agent activity in patients with relapsed or refractory multiple myeloma, a finding that supports further ...

DREAMM-6: Safety, Tolerability and Clinical Activity of ...

Clinical benefit rate was 83% (95% CI 58.6-96.4). After a median of 18.2 weeks (range 6.0-46.4 weeks) on treatment, median DoR was not reached.

Exposure-response analyses for belantamab mafodotin in ...

An initial belantamab mafodotin dose of 2.5 mg/kg for BVd yields deeper responses with minimal change in safety outcomes versus 1.9 mg/kg for ...