Belantamab Mafodotin Combinations for Multiple Myeloma
(DREAMM5 Trial)
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive belantamab mafodotin in combination with other anti-cancer drugs
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Belantamab mafodotin
Belantamab mafodotin is already approved in United States, European Union for the following indications:
- Relapsed or refractory multiple myeloma (approval withdrawn)
- Relapsed or refractory multiple myeloma
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Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
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