CARTITUDE-4
Research type
Research Study
Full title
A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA, versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with Relapsed and Lenalidomide-Refractory Multiple Myeloma
IRAS ID
275690
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2019-001413-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 5 months, 21 days
Research summary
This is a Phase 3, randomised, open-label multicentre study which aims to compare whether the study medication (called JNJ-68284528) is effective at treating participants with multiple myeloma, as compared with the standard medications. Side effects of the treatments will also be studied and compared.
JNJ-68284528 is a CAR-T cell therapy. T cells (a type of white blood cell) form part of the body’s immune system. T cells are not able to recognise multiple myeloma cells. CAR-T cells are made by taking a patient’s own T cells and modifying them, so they recognise a protein called BCMA (B cell maturation antigen), which is found on the surface of most myeloma cells. The JNJ-68284528 CAR-T cells can recognise BCMA, bind to the myeloma cells and kill them.
Participants who meet the inclusion criteria (including having been diagnosed with multiple myeloma, and having received 1-3 courses of different treatments, known as 'lines'), will be randomly selected to receive either standard treatment (Arm A: Pomalidomide, Bortezomib and Dexamethasone [PVd] or Daratumumab, Pomalidomide and Dexamethasone [DPd]) or the study medication (Arm B). Participants will be followed-up after completing the treatment phase. Participants in Arm B will also continue to be followed-up after the completion of this trial, as they will be entered in to a separate study to observe them for 15 years.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/LO/0181
Date of REC Opinion
15 May 2020
REC opinion
Further Information Favourable Opinion