A post-authorisation, non-interventional, retrospective, drug-utilisation study to describe the pattern of use of lenalidomide in patients with myelodysplastic syndromes (MDS) (CC-5013-MDS-012)

Study identification

• EU PAS number:
  EUPAS22604
• Study ID:
  47927
• Official title and acronym:
  A post-authorisation, non-interventional, retrospective, drug-utilisation study to describe the pattern of use of lenalidomide in patients with myelodysplastic syndromes (MDS) (CC-5013-MDS-012)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Czechia

  Denmark

  France

  Germany

  Greece

  Netherlands

  Poland

  Portugal

  Spain

  Sweden

  United Kingdom (Northern Ireland)

  United States
• Study description:
  This is a post-authorisation, non-interventional, retrospective, drug-utilisation study. This study will be run in countries in the EU in which Revlimid (lenalidomide) is approved and marketed for the MDS indication and where these patients were subsequently granted access to the drug through reimbursement schemes. ; The only exception is that eligible patients from the company-sponsored Connect® Myeloid Disease Registry (US Cohort Registry) will be included regardless of start date of treatment to assess the secondary safety objectives (but not the primary drug-utilisation objective due to a different MDS indication approved in the US). ; This retrospective drug-utilisation study will include patients with MDS treated with lenalidomide, irrespective if within or outside the authorized indication in the EU (eg, patients commencing lenalidomide treatment for transfusion-dependent IPSS low- or int-1-risk MDS with isolated del(5q) or with additional cytogenetic abnormalities, or IPSS risk categories intermediate-2 (int-2) -or high, or patients with MDS without del(5q) will also be recorded).
• Study status:
  Finalised

Research institutions and networks

Institutions

Celgene International

Study timelines

Date when funding contract was signed

Planned: 30/11/2017

Actual: 31/07/2018

Study start date

Planned: 31/10/2018

Actual: 08/11/2018

Date of interim report, if expected

Planned: 31/03/2019

Actual: 21/03/2019

Date of final study report

Planned: 28/06/2024

Actual: 21/05/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

CELGENE INTERNATIONAL SARL, a BRISTOL MYERS SQUIBB COMPANY

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)