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
RevlimidPMS
Post Marketing Surveillance on Safety Evaluation of REVLIMID® (Lenalidomide) Treatment of Myelodysplastic Syndromes Associated With a Deletion 5q or Mantle Cell Lymphoma in Korea
2 other identifiers
observational
28
1 country
26
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2019
Typical duration for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2019
CompletedFirst Posted
Study publicly available on registry
July 29, 2019
CompletedStudy Start
First participant enrolled
November 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2023
CompletedMarch 11, 2025
March 1, 2025
3.7 years
July 25, 2019
March 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events (AEs)
Number of participants with adverse event
From enrollment until at least 28 days after completion of study treatment
Secondary Outcomes (4)
Adverse events (AEs)
From enrollment until at least 28 days after completion of study treatment
To evaluate the effectiveness of REVLIMID® treatment in patients with IPSS low- or intermediate-1-risk del (5q) MDS
Up to 4 years of Revlimid treatment period
To evaluate the effectiveness of REVLIMID® treatment in patients with rrMCL
Up to 4 years of Revlimid treatment period
To evaluate the effectiveness of REVLIMID® treatment in patients with previously treated FL
Up to 4 years of Revlimid treatment period
Study Arms (2)
Lenalidomide in IPSS Low-or intermediate-1-risk del population
For the IPSS Low- or intermediate-1-risk del (5q) (MDS), Lenalidomide treatment must not be started if the ANC \< 0.5 x 109/L and/or platelet counts \< 25 x 109/L. The recommended starting dose of lenalidomide is 10 mg orally once daily on days 1 to 21 of repeated 28-day cycles.
Lenalidomide in Refractory/relapsed rrMC/ Follicular lymphoma population
For the Refractory/relapsed Mantle cell lymphoma (rrMCL), the recommended starting dose of lenalidomide is 25 mg orally once daily on days 1 to 21 of repeated 28-day cycles. For the Follicular lymphoma (FL), the recommended starting dose of rituximab is 375 mg/m2 intravenously (IV) every week in Cycle 1 (days 1, 8, 15, and 22) and day 1 of every 28-day cycle for Cycles 2 through 5.
Interventions
REVLIMID®
Eligibility Criteria
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 for IPSS low- or intermediate-1-risk del (5q) MDS, rrMCL and previously treated Follicular lymphoma.
You may qualify if:
- Treatment of patients with transfusion-dependent anemia due to IPSS low- or intermediate-1-risk Myelodysplastic Syndromes associated with a deletion 5q cytogenetic abnormality according to International scoring system for evaluating prognosis in myelodysplastic syndromes according to IPSS or
- Treatment of patients with mantle cell lymphoma who have received at least one prior therapy
- Previously treated follicular lymphoma (FL)
- Patients who are registered in Celgene Risk Management Program" in Korea
You may not qualify if:
- Pregnancy or females of childbearing potential
- Hypersensitivity to the active substance or to any of the excipients (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS)
- Patients with genetic disorder (e.g., galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (26)
Local Institution - S02
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Hallym University Medical Center
Anyang, 14068, South Korea
Keimyung University Dongsan Hospital
Daegu, 41931, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Local Institution - S03
Daegu, 700-712, South Korea
Local Institution - S07
Daegu, 700-721, South Korea
Local Institution - S11
Goyang, 411-719, South Korea
CHONNAM National University Hwasun Hospital
Hwasun, 58128, South Korea
Local Institution - S04
Hwasun-gun, 519-809, South Korea
Naitonal Health Insurance Service Ilsan hospital
Ilsan, 10444, South Korea
Gachon University Gil Mdical Center
Incheon, 21565, South Korea
Local Institution - S09
Incheon, 21565, South Korea
Jeonbuk National University Hospital
Jeonju, 54896, South Korea
Local Institution - S10
Jeonju, 54907, South Korea
Local Institution - S05
Seoul, 03080, South Korea
Local Institution - S06
Seoul, 03080, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Local Institution - S08
Seoul, 03722, South Korea
Yonsei University Severance Hospital
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Local Institution - S12
Seoul, 06351, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Local Institution - S01
Seoul, 06591, South Korea
The Catholic University, St. Mary's Hospital
Seoul, 06591, South Korea
Local Institution - S14
Wŏnju, 26426, South Korea
Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Claire (Myoung-Jin) Lee, Medical doctor
Celgene Korea
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2019
First Posted
July 29, 2019
Study Start
November 28, 2019
Primary Completion
August 15, 2023
Study Completion
August 15, 2023
Last Updated
March 11, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- See Plan Description
- Access Criteria
- See Plan Description
Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/