Status: Ongoing First registered on: 12/05/2017
Last updated on: 22/02/2021
1. Study identification
EU PAS Register NumberEUPAS10153
Official titleA 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”)
Study title acronymCC-5013-MM-034
Study typeObservational study
Brief description of the studyThe purpose of the Revlimid TNE NDMM Registry is to provide accurate clinical information regarding the safety profile of lenalidomide relative to other first-line regimens when prescribed for TNE NDMM patients across a variety of diverse clinical settings, particularly with respect to the cardiovascular safety profile of lenalidomide. The study will gather extensive risk factor information at baseline and throughout follow-up to aid in the interpretation of any observed differences in the incidence of cardiovascular events between the two cohorts. Other safety endpoints of interest will be characterized through standard follow-up procedures.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableUTN number: U1111-1194-5810
2. Research centres and Investigator details
Coordinating study entity
Centre nameCELGENE INTERNATIONAL SARL
Centre locationBOUDRY SWITZERLAND
Details of (Primary) lead investigator
Title Ms
Last name Celgene International Sarl
First name Medical Affairs
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?118
see attached document for site list, see attached document for site list
Countries in which this study is being conducted
International study

Austria
Belgium
Denmark
France
Germany
Ireland
Italy
Netherlands
Norway
Spain
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed10/05/201610/05/2016
Start date of data collection31/03/201731/03/2017
Start date of data analysis
Date of interim report, if expected
Date of final study report13/10/2026
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesCELGENE INTERNATIONAL SARL100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Ms
Last name Celgene International Sarl
First name Medical Affairs
Address line 1Route des Perreux 1
Address line 2 
Address line 3 
CityBoudry 
Postcode2017 
CountrySwitzerland
Phone number (incl. country code)41-3272-98500 
Alternative phone number 
Fax number (incl. country code) 
Email address WWM-MA-HemOnc-SponsoredStudies@bms.com
Public Enquiries
Title Ms 
Last name Celgene International Sarl 
First name Medical Affairs 
Address line 1Route des Perreux 1 
Address line 2 
Address line 3 
CityBoudry 
Postcode2017 
CountrySwitzerland 
Phone number (incl. country code)41-3272-98500 
Alternative phone number 
Fax number (incl. country code) 
Email address WWM-MA-HemOnc-SponsoredStudies@bms.com 
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