207499 DREAMM 8
Research type
Research Study
Full title
A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination with Pomalidomide and Dexamethasone (B-Pd) versus Pomalidomide plus Bortezomib and Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma (DREAMM 8)
IRAS ID
292045
Contact name
Hannah Hunter
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2018-004354-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 1 months, 30 days
Research summary
This research study is being done to learn more about multiple myeloma (MM). The study will test if the investigational study treatment, called belantamab mafodotin (also referred to as GSK2857916), can help patients who have already received at least one other treatment and whose MM has worsened. This type of MM is called relapsed/refractory MM or RRMM. In this study, belantamab mafodotin will be given in combination with two other drugs that are currently approved to treat MM, pomalidomide and dexamethasone (abbreviated to pom/dex).
Adult patients with Relapsed/Refractory Multiple Myeloma will be eligible to participate in this study if they meet all of the inclusion criteria and none of the exclusion criteria as listed in the study Protocol. The study will include about 450 study participants and will last for approximately 5 years.
The study will include a screening period, study treatment period, and follow-up. During screening participants will be evaluated for study eligibility per protocol as defined in the Inclusion and Exclusion criteria. Following screening, eligible participants will be divided into 2 treatment arms (referred to as Arm A and Arm B). Arm A participants will receive the investigational study treatment, belantamab mafodotin. Arm B participants will receive the comparator study treatment bortezomib plus pom/dex. The effects of the drugs will be compared between the two treatment arms.
The study assessments will be performed during Screening, prior to the first dose of Cycle 1, and during each cycle of treatment. Upon completion of study treatment, participants will enter the follow-up phase.
REC name
Scotland B REC
REC reference
21/SS/0007
Date of REC Opinion
26 Mar 2021
REC opinion
Further Information Favourable Opinion