Daratumumab + rd vs rd in subjects with previously untreated MM
Research type
Research Study
Full title
A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Previously Untreated Multiple Myeloma who are Ineligible for High Dose Therapy.
IRAS ID
165595
Contact name
Mohammed Haq
Contact email
Sponsor organisation
Janssen-Cliag International NV
Eudract number
2014-002273-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 0 days
Research summary
Multiple Myeloma is a type of bone marrow cancer which affects the plasma cells (a type of blood cell) inside the bone marrow, which is an important part of the immune system. The purpose of this study is to find out how well daratumumab works when given along with two other drugs called Revlimid® (lenalidomide) and Dexamethasone to treat previously untreated multiple myeloma and how safe it is. Daratumumab is a fully human monoclonal antibody. An antibody finds and kills foreign objects (“antigens”here myeloma cells) in the body. Daratumumab is not approved for use by the MHRA, U.S. Food and Drug Administration (FDA) or any other Regulatory Authority. The combination of Revlimid® and dexamethasone has been approved for the treatment of adults with previously untreated Multiple Myeloma ineligible for stem cell transplant by FDA and EMA. This is a randomised (participants will be assigned treatment by chance), open label (both the study doctor and the participant will know which treatment they have been assigned to), multicentre study in participants at least 18 years of age.
Treatment groups:
Treatment arm A: Revlimid® and dexamethasone
Treatment arm B: Daratumumab plus Revlimid® and dexamethasone
Daratumumab will be administered until the disease worsens at 16 mg/kg (IV infusion) weekly for 8 weeks (cycle 1 and 2), every 2 weeks for 16 weeks (cycles 3 to 6), thereafter monthly.730 participants will be enrolled worldwide.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
15/SW/0086
Date of REC Opinion
1 Jun 2015
REC opinion
Further Information Favourable Opinion