Observational Study to Evaluate the Effectiveness of Lenalidomide
Research type
Research Study
Full title
A Multicenter, Observational Study to Evaluate the Effectiveness of Lenalidomide (Revlimid®) in Subjects With Mantle Cell Lymphoma Who Have Relapsed or Progressed After Treatment With Ibrutinib or Are Refractory or Intolerant to Ibrutinib
IRAS ID
179376
Contact name
Simon Rule
Contact email
Sponsor organisation
Celgene International S.a.r.l
Duration of Study in the UK
0 years, 3 months, 15 days
Research summary
This is a non-interventional study to determine the activity and safety of lenalidomide either as monotherapy or as combination in relapsed or refractory mantle cell lymphoma (MCL) patients following ibutinib treatment. MCL patients who require treatment after receiving ibrutinib therapy are considered a population with high unmet medical need. It is therefore of benefit to have data on the outcomes of treatment options available in this patient population.
Data will be extracted from the medical records that is already existing or being recorded for MCL patients treated with lenalidomide.MCL patients who received lenalidomide either as monotherapy or as combination treatment after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant to ibrutinib treatment are eligible for the study. Lenalidomide does not need to be the next subsequent treatment after ibrutinib.
Data of approximately 30 patients will be included in this study. About 6 patients will be recruited in the UK.
Participants will require to sign consent. All patients will have retrospective (looking back in time) data collection.There are no study procedures associated with this study.
This study is funded by Celgene Corporation.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
15/NW/0397
Date of REC Opinion
18 May 2015
REC opinion
Further Information Favourable Opinion