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)

Study identification

• 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

Celgene International

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

Study timelines

Date when funding contract was signed

Planned:10/05/2016

Actual:10/05/2016

Study start date

Planned:31/03/2017

Actual:31/03/2017

Date of final study report

Planned:13/10/2026

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)

Other study registration identification numbers and links

UTN number: U1111-1194-5810