Status: Finalised First registered on: 08/07/2014
Last updated on: 02/08/2017
1. Study identification
EU PAS Register NumberEUPAS7023
Official titleDatabase study of lenalidomide (Revlimid®) in Germany: Monitoring off-label use
Study title acronym
Study typeObservational study
Brief description of the studyIn 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.
Was this study requested by a regulator?Yes: Germany
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBIPS GmbH
Department/Research groupClinical Epidemiology
Organisation/affiliationLeibniz Inst. for Prevention Research and Epidem.
Website/Homepagewww.bips.uni-bremen.de
Details of (Primary) lead investigator
Title Dr
Last name Riedel
First name Oliver
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/04/200815/04/2008
Start date of data collection06/05/200806/05/2008
Start date of data analysis08/05/200908/05/2009
Date of interim report, if expected05/05/201405/05/2014
Date of final study report31/12/201417/12/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesCelgene GmbH100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Riedel
First name Oliver
Address line 1Achterstraße 30
Address line 2 
Address line 3 
CityBremen 
Postcode 
CountryGermany
Phone number (incl. country code)004942121856860 
Alternative phone number 
Fax number (incl. country code) 
Email address gepard@leibniz-bips.de
Public Enquiries
Title Dr 
Last name Riedel 
First name Oliver 
Address line 1Achterstraße 30 
Address line 2 
Address line 3 
CityBremen 
Postcode 
CountryGermany 
Phone number (incl. country code)004942121856860 
Alternative phone number 
Fax number (incl. country code) 
Email address gepard@leibniz-bips.de 
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