209 Participants Needed

Belantamab Mafodotin Combinations for Multiple Myeloma

(DREAMM5 Trial)

Recruiting at 57 trial locations
UG
EG
Overseen ByEU GSK Clinical Trials Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: GlaxoSmithKline
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

Trial Summary

What is the purpose of this trial?

B-cell maturation antigen (BCMA) is a target present on tumor cells in participants with multiple myeloma. Belantamab mafodotin (GSK2857916); is an antibody-drug conjugate (ADC) containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I/II, randomized, open-label, platform study designed to evaluate the effects of belantamab mafodotin in combination with other anti-cancer drugs in participants with relapsed/refractory multiple myeloma. The Platform design incorporates a single master protocol, where multiple treatment combinations, as sub-studies, will be evaluated simultaneously.

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 cannot have had other monoclonal antibodies within 30 days or systemic anti-myeloma therapy within 14 days before starting the study. Also, certain HIV drugs are restricted if you are receiving nirogacestat. It's best to discuss your specific medications with the trial team.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had other monoclonal antibodies within 30 days or systemic anti-myeloma therapy within 14 days before starting the study. It's best to discuss your specific medications with the trial team.

What data supports the idea that Belantamab Mafodotin Combinations for Multiple Myeloma is an effective drug?

The available research shows that Belantamab Mafodotin, when used alone, has shown positive results in treating multiple myeloma. In the DREAMM-2 study, it achieved a response rate of 32% in patients who had already tried several other treatments. Another study from France reported a 38.1% response rate, with patients living a median of 9.3 months after starting the treatment. These results suggest that Belantamab Mafodotin can be effective for patients who have not responded to other treatments. However, it is important to note that some patients experienced side effects, particularly eye-related issues.12345

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

Belantamab mafodotin has shown effectiveness in treating relapsed or refractory multiple myeloma, with studies reporting an overall response rate of 32% in heavily pretreated patients and a median overall survival of 9.3 months. It works by targeting and killing myeloma cells, and has been effective even in patients who have tried multiple other treatments.12345

What safety data is available for Belantamab Mafodotin in treating Multiple Myeloma?

The provided research does not contain specific safety data for Belantamab Mafodotin or its various names in the context of treating Multiple Myeloma. The articles focus on adverse drug reactions related to other medications and conditions, such as genetic associations with severe adverse drug reactions, drug-associated agranulocytosis, and myelotoxicity in inflammatory bowel disease treatments. For specific safety data on Belantamab Mafodotin, further research or clinical trial results specific to this drug would be needed.678910

Is the drug Belantamab Mafodotin a promising treatment for multiple myeloma?

Yes, Belantamab Mafodotin is a promising drug for multiple myeloma. It targets a specific protein on cancer cells, leading to their destruction. Studies show it works well alone and even better when combined with other treatments, offering hope for patients who have tried many other therapies.1231112

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 toxic payload directly to the cancer cells. It also has immunomodulatory effects, meaning it can help the immune system fight the cancer, and is being studied in combination with other novel agents to enhance its effectiveness.1231112

Research Team

GC

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

Adults with a confirmed diagnosis of Multiple Myeloma who have tried at least three prior treatments, including an immunomodulating agent and a proteasome inhibitor. They must have measurable disease, be in good physical condition (ECOG 0-1), and not have had certain recent treatments or uncontrolled diseases. Specific criteria apply for participants from Japan and China.

Inclusion Criteria

Participants with contraception requirements specific to Sub-study 6, 7, and 8 respectively.
I tested positive for Hepatitis B core antibody but do not have active Hepatitis B.
I am currently taking low-dose oral steroids, inhaled steroids, or eye steroids.
See 8 more

Exclusion Criteria

I received CAR-T therapy with chemotherapy less than 3 months ago.
I stopped a previous cancer treatment due to severe side effects.
I have low levels of phosphate, potassium, or magnesium that don't improve with treatment.
See 33 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive belantamab mafodotin in combination with other anti-cancer drugs

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 36 months

Treatment Details

Interventions

  • Belantamab mafodotin
Trial OverviewThe trial is testing Belantamab Mafodotin alone or combined with other anti-cancer drugs in those with relapsed/refractory Multiple Myeloma. It's an open-label study where different drug combinations are tested simultaneously to see how well they work.
Participant Groups
17Treatment groups
Experimental Treatment
Active Control
Group I: Belantamab mafodotin+nirogacestat dose exploration(Sub-study 3)Experimental Treatment2 Interventions
Group II: Belantamab mafodotin+isatuximab dose exploration (Sub-study 5)Experimental Treatment2 Interventions
Group III: Belantamab mafodotin+feladilimab dose exploration (Sub-study 2)Experimental Treatment2 Interventions
Group IV: Belantamab mafodotin+dostarlimab dose exploration(Sub-study 4)Experimental Treatment2 Interventions
Group V: Belantamab mafodotin+GSK3174998 dose exploration (Sub-study 1)Experimental Treatment2 Interventions
Group VI: Belantamab mafodotin+GSK3174998 cohort expansion (Sub-study 1)Experimental Treatment2 Interventions
Group VII: Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone dose exploration (Sub-study 7)Experimental Treatment4 Interventions
Group VIII: Belantamab mafodotin+ nirogacestat+ pomalidomide + dexamethasone cohort expansion (Sub-study 7)Experimental Treatment4 Interventions
Group IX: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone dose exploration (Sub-study 8)Experimental Treatment4 Interventions
This cohort will enroll Northeast Asian participants.
Group X: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone dose exploration (Sub-study 6)Experimental Treatment4 Interventions
Group XI: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone cohort expansion (Sub-study 8)Experimental Treatment4 Interventions
This cohort will enroll Northeast Asian participants.
Group XII: Belantamab mafodotin+ nirogacestat+ lenalidomide+ dexamethasone cohort expansion (Sub-study 6)Experimental Treatment4 Interventions
Group XIII: Belantamab mafodotin+ nirogacestat cohort expansion (Sub-study 3)Experimental Treatment2 Interventions
Group XIV: Belantamab mafodotin+ isatuximab cohort expansion (Sub-study 5)Experimental Treatment2 Interventions
Group XV: Belantamab mafodotin+ feladilimab cohort expansion (Sub-study 2)Experimental Treatment2 Interventions
Group XVI: Belantamab mafodotin+ dostarlimab cohort expansion (Sub-study 4)Experimental Treatment2 Interventions
Group XVII: Belantamab mafodotin monotherapy cohort expansionActive Control1 Intervention

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

🇺🇸
Approved in United States as Blenrep for:
  • Relapsed or refractory multiple myeloma (approval withdrawn)
🇪🇺
Approved in European Union as Blenrep for:
  • Relapsed or refractory multiple myeloma

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

Findings from Research

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.
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 (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]

References

Belantamab mafodotin in combination with novel agents in relapsed/refractory multiple myeloma: DREAMM-5 study design. [2021]
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]
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. [2023]
Real-World Outcomes of Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results of a Spanish Expanded Access Program (EAP). [2023]
An Updated Review of Genetic Associations With Severe Adverse Drug Reactions: Translation and Implementation of Pharmacogenomic Testing in Clinical Practice. [2022]
Drug-associated agranulocytosis: 20 years of reporting in The Netherlands (1974-1994). [2019]
Risk of Hemolytic Anemia in IBD Patients with Glucose-6-Phosphate Dehydrogenase Deficiency Treated with Mesalamine: Results of a Retrospective-Prospective and Ex Vivo Study. [2023]
Idiosyncratic drug-induced agranulocytosis: Update of an old disorder. [2006]
10.United Statespubmed.ncbi.nlm.nih.gov
Thiopurine-induced myelotoxicity in patients with inflammatory bowel disease: a review. [2017]
Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Belantamab Mafodotin (GSK2857916) Drives Immunogenic Cell Death and Immune-mediated Antitumor Responses In Vivo. [2023]