Belantamab Mafodotin for Multiple Myeloma
(DREAMM12 Trial)
Trial Summary
What is the purpose of this trial?
Belantamab mafodotin is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Renal impairment is a major complication of multiple myeloma (MM) and the majority of MM participants is either at risk or already has renal dysfunction at initial diagnosis. The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in participants with RRMM, who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation ) and have either normal or impaired renal functions. The study will consist of two parts: part 1 will include participants with normal/mildly impaired renal function and severe renal impairment and part 2 will include participants with end-stage renal disease (ESRD), where participants are either not undergoing or require hemodialysis. Participants will be administered belantamab mafodotin at a dose of 2.5 milligram per kilogram (mg/kg) intravenously once in three weeks (Q3W) dosing in Part 1. Based on the Part 1 Safety/Pharmacokinetic (PK) data, Part 2 participants will be administered the dose of either 2.5 mg/kg or 1.9 mg/kg (or other adjusted dose). Participants will be treated with belantamab mafodotin monotherapy until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first. This study will include a screening phase, treatment phase, follow-up phase and a post analysis continued treatment (PACT) phase . The total duration of the study is approximately up to 48 months.
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 received an investigational drug or a strong Organic-anion transporting polypeptide inhibitor within 14 days or 5 half-lives before the first dose of the study drug. It's best to discuss your current medications with the trial team.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received certain investigational drugs or strong inhibitors within a specific timeframe before the study. It's best to discuss your current medications with the study team to get a clear answer.
What data supports the idea that Belantamab Mafodotin for Multiple Myeloma is an effective drug?
The available research shows that Belantamab Mafodotin is effective for treating multiple myeloma, especially in patients who have already tried several other treatments. In the DREAMM-2 study, about 32% of patients who had been heavily pretreated showed a positive response to the drug. This means that nearly one-third of the patients experienced a reduction in their cancer after using Belantamab Mafodotin. Additionally, the drug has been approved in the USA and EU for patients who have tried at least four other therapies, indicating its effectiveness in difficult cases.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 a 32% overall response rate in patients who had already undergone several treatments, as demonstrated in the DREAMM-2 study. It works by targeting and killing myeloma cells, and has been approved for use in patients who have tried at least four other therapies.12345
What safety data is available for Belantamab Mafodotin in treating multiple myeloma?
Belantamab Mafodotin has been evaluated in several studies, including the DREAMM-1 and DREAMM-2 trials, and has shown manageable safety in patients with relapsed/refractory multiple myeloma. Common adverse effects include ocular toxicity, such as keratopathy, blurred vision, and changes in visual acuity, with keratopathy being the most frequent. Thrombocytopenia and infections are also noted adverse effects. The FDA has approved it with a boxed warning for ocular toxicity, and it is available under a Risk Evaluation and Mitigation Strategy. Real-world studies confirm these findings, showing a tolerable toxicity profile similar to clinical trials.36789
Is Belantamab Mafodotin safe for humans?
Belantamab Mafodotin has been shown to have manageable safety in patients with multiple myeloma, but it can cause significant side effects, particularly eye-related issues like keratopathy (eye damage) and blurred vision. Other common side effects include low platelet counts (thrombocytopenia) and infections, and it is available only through a restricted program due to these risks.36789
Is the drug Belantamab Mafodotin a promising treatment for Multiple Myeloma?
Yes, Belantamab Mafodotin is a promising drug for treating Multiple Myeloma. It has shown strong anti-cancer effects in patients who have already tried several other treatments. It works by targeting and killing cancer cells, and it has been approved for use in the USA and EU for patients with relapsed or refractory Multiple Myeloma.12346
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 on myeloma cells, delivering a powerful cancer-killing agent directly to the cells. This drug is specifically designed for patients who have already tried multiple other treatments, offering a new option for those with relapsed or refractory multiple myeloma.12346
Research Team
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Eligibility Criteria
This trial is for adults with multiple myeloma who've had at least 3 prior treatments (or 2 if they couldn't have a stem cell transplant) and have varying degrees of kidney function, including severe impairment or end-stage renal disease. Participants must be able to consent, follow study rules, and use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive belantamab mafodotin monotherapy with dosing every 21 days until disease progression or other endpoints
Follow-up
Participants are monitored for safety and effectiveness after treatment
Post Analysis Continued Treatment (PACT)
Participants may continue treatment based on analysis of safety and pharmacokinetic data
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