DREAMM 3 (207495)
Research type
Research Study
Full title
A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide plus Lowdose Dexamethasone (pom/dex) in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 3)
IRAS ID
273791
Contact name
Heather Oakervee
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd
Eudract number
2018-004252-38
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
4 years, 4 months, 7 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 with worsening MM who have already failed at least two other treatments (called relapsed/refractory MM).
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 320 study participants and will last for approximately 4–5 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, participants will be divided into 2 treatment arms (referred to as Arm 1 and Arm 2). Arm 1 will receive the investigational study treatment, belantamab mafodotin. Arm 2 will receive the comparator study treatment pomalidomide and low-dose dexamethasone (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
London - West London & GTAC Research Ethics Committee
REC reference
20/LO/0165
Date of REC Opinion
14 Apr 2020
REC opinion
Further Information Favourable Opinion