CC-5013-MM-034_A non-interventional study of lenalidomide
Research type
Research Study
Full title
A prospective non-interventional post-authorization safety study (PASS) of lenalidomide in previously untreated adult multiple myeloma patients who are not eligible for transplant (“transplant noneligible” [TNE]) (“Revlimid TNE NDMM PASS”)
IRAS ID
271912
Contact name
Cesar Gomez
Contact email
Sponsor organisation
Celgene International Sarl
Duration of Study in the UK
5 years, 1 months, 19 days
Research summary
Multiple myeloma is a cancer of plasma cells (a type of immune cell that produces antibodies) in the bone marrow. Revlimid® has been approved for the treatment of Multiple Myeloma (MM) and is indicated for the treatment of adult patients with previously untreated MM who are not eligible for transplant.
Patients who are being treated with either Revlimid® (Revlimid® is the brand name for lenalidomide) or another anti-myeloma drug or drug combination will be eligible to take part in this study. This study will collect information about Revlimid® and other anti-myeloma treatments.
The purpose of this study is to collect more information about the safety profile of the patient’s treatment. It is not the purpose of this study to test a new experimental product. This study will not have any influence on the treatment or the way the study doctor is monitoring the patient’s health and treatment. The patient’s will not be asked to take any new experimental or unapproved medicine for the purpose of this study.This study will enrol patients into two arms, one arm for patients receiving Revlimid® and the other arm for patients receiving any other treatment. The main focus of this study is to collect data on cardiovascular (heart and blood vessels) reactions when being treated with Revlimid®, however cardiovascular reactions will also be closely observed in patients treated with any other anti-myeloma treatment.
888 patients within Europe will take part in this study across approximately 120 sites. It is expected that there will be approximately 10-20 sites and approximately 60 patients recruited in the UK. The maximum duration for data collection during treatment will be 3 years, with an additional data collection 6 months later, and follow-up information up to 5 years from treatment start. During the follow up period, patients will be contacted twice per year.
REC name
HSC REC B
REC reference
19/NI/0216
Date of REC Opinion
20 Nov 2019
REC opinion
Favourable Opinion