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A Non-interventional Study of REVLIMID® (Lenalidomide) Treatment of IPSS Low- or Intermediate-1-risk Myelodysplastic Syndromes Associated With a Deletion 5q or Refractory/Relapsed Mantle Cell Lymphoma in Korea

NCT04036448 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2025-03-11

No results posted yet for this study

Summary

The Drug Use Examination (DUE) is planned and designed for the safety evaluation of new indications after the approval of a new drug in Korea.

This DUE is a non-interventional, observational and post-marketing surveillance, which will be conducted by collecting the safety information of REVLIMID® for new indications in routine clinical practice in Korea.

Six-Hundred (600) adult patients, who start with REVLIMID® treatment based on the approved local package insert (PI) of REVLIMID® during routine clinical practice in Korea and have indications noted below.

1. Patients with transfusion-dependent anemia due to IPSS low- or intermediate-1-risk Myelodysplastic Syndromes associated with a deletion 5q cytogenetic abnormality (del \[5q\] MDS)
2. Patients with mantle cell lymphoma who have received at least one prior therapy (rrMCL)
3. Previously treated follicular lymphoma (FL), in combination with rituximab (an anti-CD20 antibody)

Conditions

Interventions

DRUG

REVLIMID®

REVLIMID®

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Claire (Myoung-Jin) Lee, Medical doctor · Celgene Korea

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-28
Primary Completion
2023-08-15
Completion
2023-08-15

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT04036448 on ClinicalTrials.gov