Belantamab Mafodotin + Lenalidomide + Dexamethasone for Multiple Myeloma
(DREAMM-10 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a new treatment combination can help people with multiple myeloma, a type of blood cancer, live longer without disease progression. It tests two groups: one receiving belantamab mafodotin (an antibody-drug conjugate) with lenalidomide and dexamethasone, and the other receiving daratumumab with the same two drugs. Individuals recently diagnosed with multiple myeloma who are not candidates for a stem cell transplant might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier studies combining belantamab mafodotin with lenalidomide and dexamethasone revealed some safety concerns. Research found that serious side effects occurred in about 53% of patients, with rare cases being severe and one linked to the treatment. However, these results stem from early testing stages, which often aim to determine the safest dose.
Daratumumab, in contrast, has been used for a while and is approved for other treatments, with its safety generally well understood. Overall, the combination of these treatments appears promising, but potential risks must be considered. Prospective participants should consult their healthcare provider to understand the implications of joining a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for multiple myeloma because they offer innovative approaches to tackling the disease. Belantamab mafodotin is unique because it’s an antibody-drug conjugate, which means it combines a targeted antibody with a powerful anti-cancer agent, directly delivering the drug to cancer cells while sparing healthy ones. This targeted approach could potentially result in fewer side effects compared to traditional chemotherapy. On the other hand, daratumumab works by targeting a protein called CD38 on myeloma cells, enhancing the immune system's ability to fight the cancer. These mechanisms provide promising alternatives to the standard treatments like bortezomib and carfilzomib, opening new avenues for patients who might not respond well to existing therapies.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
In this trial, participants will receive either Belantamab Mafodotin or Daratumumab, each combined with lenalidomide and dexamethasone. Studies have shown that Belantamab Mafodotin, when used with other drugs, effectively treats multiple myeloma, a type of blood cancer. The DREAMM-7 study found that Belantamab Mafodotin outperformed Daratumumab when combined with bortezomib and dexamethasone. Other research also supports its effectiveness, especially for patients who have tried many other treatments. Conversely, Daratumumab, also tested in this trial, is a well-known treatment for multiple myeloma. It has improved outcomes when used with medications like lenalidomide and dexamethasone. Both treatments help control the disease and improve patients' quality of life.36789
Are You a Good Fit for This Trial?
This trial is for adults with newly diagnosed Multiple Myeloma who can't have a stem cell transplant. They must be able to consent, need treatment per IMWG criteria, and show specific levels of M-protein or free light chains in tests. Participants should be fairly active (ECOG 0-2) and have good organ function. Men must follow local contraception rules.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Belantamab Mafodotin + Lenalidomide + Dexamethasone or Daratumumab + Lenalidomide + Dexamethasone until progressive disease, death, unacceptable toxicity, withdrawal of consent, or end of study
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Belantamab Mafodotin
- Daratumumab
Trial Overview
The study compares two treatments: BRd (Belantamab Mafodotin with Lenalidomide and Dexamethasone) versus DRd (Daratumumab with Lenalidomide and Dexamethasone). It's checking if BRd extends the time patients live without their disease getting worse or helps more patients reach no detectable cancer status.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Belantamab mafodotin, lenalidomide, and dexamethasone will be administered. Treatment will continue in both arms until progressive disease (PD), death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.
Daratumumab, lenalidomide, and dexamethasone will be administered. Treatment will continue in both arms until PD, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.
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
Citations
1.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/4751/533572/Final-Results-of-Phase-1-Clinical-Trial-ofFinal Results of Phase 1 Clinical Trial of Belantamab ...
In the DREAMM-7 study, Belamaf showed superior efficacy outcomes compared to daratumumab when combined with bortezomib and dexamethasone.
A real-world experience of efficacy and safety ...
In summary, belantamab mafodotin appeared safe and relatively effective in this real-world heavily pretreated RRMM population, where the ...
Treatment Patterns, Efficacy, and Tolerability of ...
The efficacy and safety profile of 2.5 mg/kg was favorable compared to 3.4 mg/kg.9 Subsequently, the DREAMM-3 trial compared belantamab mafodotin to ...
Real-world study of the efficacy and safety of belantamab ...
Belantamab mafodotin proved effective in the phase II DREAMM-2 trial. Based on the data from this trial, a temporary utilization program (ATU ...
Belantamab Mafodotin, Pomalidomide, and ...
At a median follow-up of 21.8 months (range, <0.1 to 39.2), the 12-month estimated progression-free survival with BPd was 71% (95% confidence ...
Belantamab mafodotin plus lenalidomide/dexamethasone ...
We report the long-term safety & efficacy results of a novel, extended dosing schedule of belantamab mafodotin (belamaf) combined with Lenalidomide & ...
Belantamab mafodotin, lenalidomide and dexamethasone ...
Overall, the rates of very good partial response and better and complete response and better were 83.3% and 52.8%, respectively, without ...
Results from Arm A of Phase 1/2 DREAMM-6 trial
SAEs were reported in 53% of patients (Table 1). SAEs were fatal in four patients, with one (febrile neutropenia) deemed related to belantamab ...
Long-Term Safety and Efficacy Results of Belantamab ...
Part 1 evaluates the safety/tolerability of three belamaf doses (2.5/1.9/1.4 mg/kg) plus Rd in 36 pts and establishes the recommended phase 2 dose (RP2D).
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