Database study of lenalidomide (Revlimid®) in Germany: Monitoring off-label use

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20223
• EU PAS number:
  EUPAS7023
• Study ID:
  20223
• Official title and acronym:
  Database study of lenalidomide (Revlimid®) in Germany: Monitoring off-label use
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  In 2007 and 2008, lenalidomide, a derivate of thalidomide, was in combination with dexamethasone indicated for the treatment of multiple myeloma in patients who have received at least one prior therapy. In this study, based on claims data with around 14 million enrollees, off-label use of lenalidomide in Germany was considered. The study is part of a risk management plan required by EMA (European Medicines Agency) and the German Federal Institute for Drugs and Medical Devices (BfArM) due to the teratogenic potential of the drug.
• Study status:
  Finalised

Research institutions and networks

Institutions

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

Study timelines

Date when funding contract was signed

Planned: 15/04/2008

Actual: 15/04/2008

Study start date

Planned: 06/05/2008

Actual: 06/05/2008

Data analysis start date

Planned: 08/05/2009

Actual: 08/05/2009

Date of interim report, if expected

Planned: 05/05/2014

Actual: 05/05/2014

Date of final study report

Planned: 31/12/2014

Actual: 17/12/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Celgene GmbH

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)