CARTITUDE-5
Research type
Research Study
Full title
A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants with Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
IRAS ID
300133
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2021-001242-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
12 years, 1 months, 11 days
Research summary
This is a phase 3, randomised, open-label multicentre study comparing bortezomib, lenalidomide and dexamethasone (known as VRd) followed by cilta-cel (the study medication) versus VRd followed by lenalidomide and dexamethasone (known as Rd) in participants with newly diagnosed multiple myeloma, for whom hematopoietic stem cell transplant is not planned as initial therapy.
Cilta-cel (ciltacabtagene autoleucel) is a CAR-T 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 cilta-cel CAR-T cells can recognise BCMA, bind to the myeloma cells and kill them.
Participants who meet the inclusion criteria will be randomly selected to receive either VRd followed by Rd (Arm A) or VRd followed by the study medication (Arm B). Participants will be followed-up over a long period following completion of 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 into a separate study to observe them for 15 years.
REC name
Scotland B REC
REC reference
21/SS/0054
Date of REC Opinion
28 Jul 2021
REC opinion
Favourable Opinion