Belantamab Mafodotin + SoC for Multiple Myeloma
(DREAMM 9 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new combination of treatments for individuals with newly diagnosed multiple myeloma, a type of blood cancer. The main goal is to assess the safety and effectiveness of belantamab mafodotin (an anti-BCMA antibody-drug conjugate) when combined with standard treatments like Velcade, Revlimid, and dexamethasone. Participants will join different groups to test varying doses and timing of these medications, aiming to identify the best approach for future studies. This trial may suit those recently diagnosed with multiple myeloma who are ineligible for high-dose chemotherapy with stem cell transplants due to other health issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
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, it does mention that participants should not have had prior systemic therapy for multiple myeloma or smoldering multiple myeloma, except for a short emergency course of steroids or focal palliative radiation. It's best to discuss your current medications with the trial investigators to get a clear answer.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to understand any potential interactions or requirements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that belantamab mafodotin may help treat relapsed or refractory multiple myeloma, meaning it has been used in patients who did not respond to other treatments. In studies with 218 patients, about 24% continued the treatment for six months or more, suggesting it can be used for a significant duration. However, some side effects were noted, with the most common being eye-related issues, such as blurred vision and dry eyes.
Belantamab mafodotin is already approved by the FDA for treating certain types of multiple myeloma. This approval indicates that its safety is somewhat understood, but it does not eliminate all risks. Prospective trial participants should be aware that previous patients have managed the treatment, but should also be prepared for possible side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about belantamab mafodotin for multiple myeloma because it represents a novel approach compared to traditional treatments like bortezomib, lenalidomide, and dexamethasone. Unlike these standard therapies, belantamab mafodotin is an antibody-drug conjugate, which means it combines a targeted antibody with a potent anti-cancer drug, allowing it to directly attack cancer cells with precision. This targeted mechanism potentially reduces damage to healthy cells and might offer a new option for patients who have become resistant to standard treatments. Additionally, the varied dosing regimens being explored could allow for more personalized treatment strategies, optimizing effectiveness while minimizing side effects.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Studies have shown that belantamab mafodotin holds promise for treating multiple myeloma, particularly in patients who have tried other treatments. In a previous study, belantamab mafodotin achieved a 45% overall response rate, with nearly half of the patients experiencing tumor reduction or disappearance. In this trial, participants will receive belantamab mafodotin combined with bortezomib, lenalidomide, and dexamethasone (VRd/Rd) across various treatment arms. Another study found that belantamab mafodotin was more effective when combined with bortezomib and dexamethasone compared to some other treatments. The drug targets a protein called BCMA on cancer cells, enhancing the immune system's ability to fight the cancer. While most research has focused on patients whose cancer returned or did not respond to other treatments, these findings offer hope for newly diagnosed patients as well.26789
Who Is on the Research Team?
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Are You a Good Fit for This Trial?
Adults over 18 with newly diagnosed multiple myeloma needing treatment, not eligible for stem cell transplant due to other health issues. They must have measurable disease, be able to perform daily activities (ECOG 0-2), and have proper organ function. Participants must use contraception and give informed consent. Excluded are those with active bleeding, liver disease, heart risks, infections requiring treatment, certain allergies or previous cancers (with exceptions), recent major surgery or therapy for multiple myeloma.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive belantamab mafodotin in combination with VRd for the first 8 cycles, followed by Rd from cycle 9 onwards. The dosing schedule varies by cohort.
End of Treatment
Participants complete an End of Treatment (EOT) visit at the point of study treatment discontinuation.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a Safety Follow-up visit 70 days after EOT.
What Are the Treatments Tested in This Trial?
Interventions
- Belantamab mafodotin
- Bortezomib
- Dexamethasone
- Lenalidomide
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
Find a Clinic Near You
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