Study identification

PURI

https://redirect.ema.europa.eu/resource/39598

EU PAS number

EUPAS10153

Study ID

39598

Official title and acronym

A 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”) (CC-5013-MM-034)

DARWIN EU® study

No

Study countries

Austria
Belgium
Denmark
France
Germany
Ireland
Italy
Netherlands
Norway
Spain
Sweden
United Kingdom

Study description

The 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.

Study status

Ongoing
Research institutions and networks

Institutions

see attached document for site list see attached document for site list

Contact details

Medical Affairs Celgene International Sarl

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

CELGENE INTERNATIONAL SARL
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 1 (imposed as condition of marketing authorisation)