Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)

NCT02279654 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 389

Last updated 2022-08-19

No results posted yet for this study

Summary

This registry is a prospective, non-interventional, post authorisation safety study for patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5 \[del(5q)\].

The purpose of this study is to collect additional data about the safety of an oral drug (lenalidomide, Revlimid®) that may have been prescribed to relieve anemia and decrease the need of blood transfusions. However, also patients affected by the MDS del(5q) who receive other treatments different from lenalidomide can be included in this study, if they agree.

Conditions

Interventions

DRUG

Lenalidomide

Lenalidomide as prescribed in routine clinical practice for low to intermediate-1 risk MDS

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-17
Primary Completion
2022-03-29
Completion
2022-03-29

Countries

  • United States
  • Belgium
  • Denmark
  • France
  • Germany
  • Greece
  • Italy
  • Luxembourg
  • Norway
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02279654 on ClinicalTrials.gov