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)

January 4, 2024 updated by: Celgene

Post Marketing Surveillance on Safety Evaluation of REVLIMID® (Lenalidomide) Treatment of Myelodysplastic Syndromes Associated With a Deletion 5q or Mantle Cell Lymphoma in Korea

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: JiHyun Park, Regional Clinical Operations
  • Phone Number: +82 2 3404 1490
  • Email: Ji-Hyun.Park@bms.com

Study Contact Backup

  • Name: Keunyoung Kim, Regional Clinical Operations
  • Phone Number: +82 2 3404 1450
  • Email: Karen.kim@bms.com

Study Locations

  • Korea, Republic of
      • Anyang, Korea, Republic of, 14068
        • Hallym University Medical Center
      • Daegu, Korea, Republic of, 41944
        • Kyungpook National University Hospital
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Hospital
      • Daegu, Korea, Republic of, 700-712
        • Local Institution - S03
      • Daegu, Korea, Republic of, 700-721
        • Local Institution - S07
      • Goyang, Korea, Republic of, 411-719
        • Local Institution - S11
      • Hwasun, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
      • Hwasun-gun, Korea, Republic of, 519-809
        • Local Institution - S04
      • Ilsan, Korea, Republic of, 10444
        • Naitonal Health Insurance Service Ilsan hospital
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Mdical Center
      • Incheon, Korea, Republic of, 21565
        • Local Institution - S09
      • JeonJu, Korea, Republic of, 54896
        • Jeonbuk National University Hospital
      • Jeonju-si, Korea, Republic of, 54907
        • Local Institution - S10
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03722
        • Yonsei University Severance Hospital
      • Seoul, Korea, Republic of, 06591
        • Local Institution - S01
      • Seoul, Korea, Republic of, 06591
        • The Catholic University, St. Mary's Hospital
      • Seoul, Korea, Republic of, 03080
        • Local Institution - S05
      • Seoul, Korea, Republic of, 03080
        • Local Institution - S06
      • Seoul, Korea, Republic of, 03722
        • Local Institution - S08
      • Seoul, Korea, Republic of, 06351
        • Local Institution - S12
      • Wonju, Korea, Republic of, 26426
        • Wonju Severance Christian Hospital
      • Wonju, Korea, Republic of, 26426
        • Local Institution - S14
    • Seoul Teugbyeolsi
      • Seoul-si, Seoul Teugbyeolsi, Korea, Republic of, 05505
        • Local Institution - S02

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: REVLIMID®
REVLIMID®
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.
Drug: REVLIMID®
REVLIMID®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AEs)
Time Frame: From enrollment until at least 28 days after completion of study treatment
Number of participants with adverse event
From enrollment until at least 28 days after completion of study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AEs)
Time Frame: From enrollment until at least 28 days after completion of study treatment
Number of participants with adverse events
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
Time Frame: Up to 4 years of Revlimid treatment period
Effectiveness evaluation for IPSS low- or intermediate-1-risk del (5q) MDS is RBC transfusion-independence response rate for ≥ 56 days (8 weeks) in patients who receive at least 2 cycles of Revlimid
Up to 4 years of Revlimid treatment period
To evaluate the effectiveness of REVLIMID® treatment in patients with rrMCL
Time Frame: Up to 4 years of Revlimid treatment period
Effectiveness evaluation for refractory/relapsed Mantle Cell Lymphoma (rrMCL) is Overall Response Rate up to 6 cycles assessed by the investigators using the Cheson Criteria, 1999
Up to 4 years of Revlimid treatment period
To evaluate the effectiveness of REVLIMID® treatment in patients with previously treated FL
Time Frame: Up to 4 years of Revlimid treatment period
Effectiveness evaluation for refractory/relapsed previously treated FL is Overall Response Rate up to 6 cycles assessed by the investigators per 2007 International Working Group criteria.
Up to 4 years of Revlimid treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Claire (Myoung-Jin) Lee, Medical doctor, Celgene Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2019

Primary Completion (Actual)

August 15, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

July 25, 2019

First Submitted That Met QC Criteria

July 25, 2019

First Posted (Actual)

July 29, 2019

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-5013-MDS-013
  • U1111-1235-2858 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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/

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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