CARTITUDE-6
Research type
Research Study
Full title
A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in Participants with Newly Diagnosed Multiple Myeloma who are Transplant Eligible
IRAS ID
1005500
Contact name
Pieter Sonneveld
Contact email
Sponsor organisation
European Myeloma Network (EMN)
Eudract number
2021-003284-10
Clinicaltrials.gov Identifier
Research summary
Multiple Myeloma (MM) is a blood cancer that develops from a type of white blood cell (plasma cells) in the bone marrow. Healthy plasma cells help fight infections but in people with MM cancerous plasma cells accumulate in the bone marrow and crowd out healthy blood cells.
The standard treatment for patients with MM includes chemotherapy and stem cell collection followed by transplantation.
This standard treatment often leads to a remission of the disease for a period of time.
Unfortunately, the disease will nearly always come back, even when the initial response has
been very favorable, therefore MM is considered to be an incurable disease.Survival rates vary but approximately 85% of people will survive for one year after diagnosis, 50% for 5 years and 30% for 10 years.
Around 6000 people are diagnosed with MM in the UK each year. MM is more common in men than women and is more common in older people. 45% of new cases are in people aged over 75 years and it is very rare in people under the age of 40 years.
The main purpose of this study is to evaluate how well the study treatment (Cilta-cel)
works compared to the standard treatment.
White blood cells will be collected and genetically modified to create this treatment which will be administered as an infusion.The study will recruit 750 participants across 110 sites in 18 countries.
The European Myeloma Network (EMN) is the Sponsor of this study and are responsible for the design. Janssen is providing financial support.REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/LO/0552
Date of REC Opinion
8 Nov 2022
REC opinion
Further Information Favourable Opinion