Daratumumab + VMP vs VMP only in newly diagnosed multiple myeloma
Research type
Research Study
Full title
A Phase 3, Randomised, Controlled, Open-label Study of VELCADE (Bortezomib Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination with VMP (D-VMP), in Subjects with Previously Untreated Multiple Myeloma who are Ineligible for High-dose Therapy
IRAS ID
165367
Contact name
Catherine Carter
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2014-002272-88
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 5 months, 22 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 and how safe it is when given along with three other drugs called Velcade®, melphalan and prednisone to treat multiple myeloma.
Daratumumab is a monoclonal human antibody. An antibody is something that finds and kills foreign objects (“antigens”) in the body; in this case myeloma cells.
Daratumumab is not approved for use by the MHRA, U.S. Food and Drug Administration (FDA) or any other Regulatory Authority. The combination of Velcade® (bortezomib), melphalan and prednisone (“VMP”) is approved for use by MHRA, U.S. Food and Drug Administration (FDA) and many Regulatory Authorities in the European Economic Area (EEA) and other countries to treat Multiple Myeloma.
There are two treatment groups in this study as follows:
Treatment Group 1: Velcade®, melphalan and prednisone (“VMP”)
Treatment Group 2: Daratumumab plus Velcade®, melphalan and prednisone (“D-VMP”)Daratumumab will be administered at 16 mg/kg (IV infusion) once every week for 6 weeks (Cycle 1); then once every 3 weeks for an additional 16 doses (Cycles 2-9); then once every 4 weeks thereafter.
Velcade will be administered at 1.3 mg/m2 SC injection) twice weekly (Weeks 1, 2, 4, and 5) for one 6-week cycle (Cycle 1; 8 doses per cycle) followed by once weekly (Weeks 1, 2, 4, and 5) administrations for eight 6-week cycles (Cycles 2 to 9; 4 doses per cycle).
Melphalan will be administered orally at 9 mg/m2 and prednisone will be administered at 60 mg/m2 on Day 1 to 4 of each VELCADE cycle.
A target of up to 700 participants will be enrolled worldwide in this study.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0009
Date of REC Opinion
29 Jan 2015
REC opinion
Favourable Opinion