DREAMM-7: Belantamab Mafodotin in Relapsed/Refractory Multiple Myeloma
Research type
Research Study
Full title
DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared with the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants with Relapsed/Refractory Multiple Myeloma
IRAS ID
276734
Contact name
Kevin Boyd
Contact email
Sponsor organisation
GSK
Eudract number
2018-003993-29
Duration of Study in the UK
6 years, 2 months, 7 days
Research summary
This study funded by GSK, will evaluate Belantamab mafodotin for the treatment of Multiple Myeloma (MM), an incurable cancer of blood plasma cells. Participants in this study will have received at least one previous standard treatment for their MM.
B-cell maturation antigen (BCMA) is a protein present on the surface of certain white blood cells and on tumour cells in patients with MM. Belantamab mafodotin, which is currently in development for the treatment of MM, is a type of antibody, which binds to BCMA and can kill tumour cells. In previous studies it’s shown significant benefit with acceptable side effects, warranting further exploration.
In this study, Belantamab mafodotin will be combined with two drugs currently used to treat MM; bortezomib (Velcade) and dexamethasone (the combination referred to as ‘B-Vd’). This combination will be compared to the combination of daratumumab and Vd (referred to as ‘D-Vd’), which is already being used to treat some patients with MM. This study will evaluate how effective B-Vd is at treating MM, compared to D-Vd.
Globally, approximately 478 participants will be involved, with about 12 participants in the UK. Half the participants will receive B-Vd and half will receive D-Vd. The treatment cycle for B-Vd is 21 days. For D-Vd it’s 21 days up to cycle 9 and 28 days thereafter. All participants will attend clinic every 21 days to have their disease evaluated. Participants will be treated until their disease worsens or unacceptable side effects. It is anticipated that participants will be in the study for an average of 21 months.
Eligible participants will begin treatment after completing screening. Participants will undergo various tests and examinations including imaging (x-ray, CT or MRI), blood samples, bone marrow samples, vital signs, ECG, physical exam, eye examinations, as well as completion of questionnaires.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0111
Date of REC Opinion
12 May 2020
REC opinion
Further Information Favourable Opinion