DREAMM-10
Research type
Research Study
Full title
A Phase 3, randomized, open-label study of belantamab mafodotin administered in combination with lenalidomide and dexamethasone (BRd) versus daratumumab, lenalidomide, and dexamethasone (DRd) in participants with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (TI-NDMM)-DREAMM-10
IRAS ID
1011347
Contact name
Sean Caltabiano
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Clinicaltrials.gov Identifier
Research summary
This study is being done to assess if the study drug, called belantamab mafodotin, can improve multiple myeloma in patients who have been newly diagnosed. Belantamab mafodotin is an antibody-drug combination, which targets specific cancer cells while limiting the damage to healthy cells. B-cell maturation antigen (BCMA) is a protein that may be found on the surface of the cancer cells of multiple myeloma. Belantamab mafodotin targets BCMA to find and destroy myeloma cancer cells.
Belantamab mafodotin (B) will be combined with 2 drugs currently used to treat multiple myeloma: lenalidomide (R) and dexamethasone (d) (the study drug combination is referred to as “BRd”). This combination will be compared to another combination of drugs, daratumumab (D), lenalidomide (R), and dexamethasone (d) (the drug combination is referred to as “DRd”), which is currently approved to treat patients with newly diagnosed multiple myeloma. The combination “DRd” is being used as a reference in this study and is called a “control”. All participants in the study will receive either BRd or DRd.
This study will test a new study drug combination called BRd, which has not yet been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Belantamab mafodotin has been successfully tested in combination with other drugs in clinical studies treating patients who had previously received other treatments for multiple myeloma.
Approximately 12 people will take part in this study in the UK. This study will have a screening period, treatment period, and a follow-up period. The number of visits is variable, and participants may visit the site more frequently based on treatment arm, test results, and how well the participant is doing.
This study is being done to test if the study drug combination works to treat people with newly diagnosed multiple myeloma, is safe, and is it better than the current standard of care (DRd).REC name
London - Fulham Research Ethics Committee
REC reference
25/LO/0156
Date of REC Opinion
14 Apr 2025
REC opinion
Further Information Favourable Opinion