Database Study of Thalidomide (Thalidomide Celgene®) in Germany: Monitoring Off-Label Use

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/16822
• EU PAS number:
  EUPAS7020
• Study ID:
  16822
• Official title and acronym:
  Database Study of Thalidomide (Thalidomide Celgene®) in Germany: Monitoring Off-Label Use
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The immunomodulator thalidomide, in combination with melphalan and prednisone is indicated for the first-line treatment of multiple myeloma in patients 65 years of age and patients for which a high-dose chemotherapy is not suitable. Aim of this project is to analyse the extent of the ambulatory off-label use (use of a drug outside the terms of its marketing authorisation) of thalidomide. 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 institution 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: 03/12/2010

Actual: 03/12/2010

Data analysis start date

Planned: 13/04/2011

Actual: 12/04/2011

Date of interim report, if expected

Planned: 10/06/2014

Actual: 10/06/2014

Date of final study report

Planned: 31/12/2014

Actual: 31/12/2014

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)?:
  Not applicable