RADAR (UK-MRA Myeloma XV)
Research type
Research Study
Full title
Risk-Adapted therapy Directed According to Response comparing treatment escalation and de-escalation strategies in newly diagnosed patients with multiple myeloma (NDMM) suitable for stem cell transplant (TE).
IRAS ID
265114
Contact name
Kwee Yong
Contact email
Sponsor organisation
University of Leeds
Eudract number
2019-001258-25
Clinicaltrials.gov Identifier
CRUK/17/012, CRUK Reference Number ; RV-CL-MM-PI-13264, Celgene Reference Number; SGZ-2018-12082, Sanofi Reference Number
Duration of Study in the UK
8 years, 0 months, 0 days
Research summary
Myeloma is a cancer of the bone marrow cells. Combining stem cell transplantation (SCT) with new drug treatments has shown to improve outcomes in myeloma patients. Some patients have been found to have genetic abnormalities in the myeloma cells and these ‘high-risk’ patients do not respond well to standard treatment. Some patients without these genetic abnormalities are also known to not respond as well to initial therapy. This study will investigate different treatment combinations for these two groups of patients. It will also investigate whether a third group of patients, who do respond well to initial treatment, can receive treatment for a shorter period of time without coming to harm. This study gives access to new treatments (the unlicensed drug isatuximab) and treatment combinations.
All participants will receive the same initial induction treatment and during this time will have genetic tests to determine whether they have ‘standard-risk’ or ‘high-risk’ disease. Following this chemotherapy treatment participants will receive ASCT (A stands for autologous, meaning that the participant's own stem cells are used).
After induction treatment participants will be allocated to a second stage treatment group based on their genetic risk, high-risk or standard-risk, and on how well the myeloma has responded to the initial treatment. Each treatment group will then receive different combinations of medication to investigate their benefit. Treatment will comprise of combinations of isatuximab, bortezomib, cyclophosphamide, lenalidomide and dexamethasone.
Newly diagnosed myeloma patients, above the age of 18 who are suitable for SCT will be eligible for the study. Patients will be required to have bone marrow, blood and urine tests throughout the trial. Participants will also be asked to complete questionnaires about their quality of life. The study will be conducted in multiple hospitals throughout the UK.
RADAR study is funded by Cancer Research UK, Celgene and Sanofi.
REC name
London - Central Research Ethics Committee
REC reference
20/LO/0238
Date of REC Opinion
14 May 2020
REC opinion
Further Information Favourable Opinion