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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

  • Clinicaltrials.gov identifier

    NCT04036448

  • Recruitment Status

    Recruiting

  • First Posted

    July 29, 2019

  • Last update posted

    April 8, 2021

Study Description

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)

  • Condition or Disease:Lymphoma, Follicular
    Lymphoma, Mantle-Cell
    Myelodysplastic Syndromes
  • Intervention/Treatment: Drug: REVLIMID®
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Observational
  • Estimated Enrollment: 600 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Post Marketing Surveillance on Safety Evaluation of REVLIMID® (Lenalidomide) Treatment of Myelodysplastic Syndromes Associated With a Deletion 5q or Mantle Cell Lymphoma in Korea
  • Actual Study Start Date: August 2019
  • Estimated Primary Completion Date: June 2022
  • Estimated Study Completion Date: June 2022

Groups and Cohorts

Groups/Cohorts 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®

Outcome Measures

  • Primary Outcome Measures: 1. Adverse events (AEs) [ Time Frame: From enrollment until at least 28 days after completion of study treatment ]
    Number of participants with adverse event
  • Secondary Outcome Measures: 1. Adverse events (AEs) [ Time Frame: From enrollment until at least 28 days after completion of study treatment ]
    Number of participants with adverse events
  • 2. 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
  • 3. 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
  • 4. 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.

Eligibility Criteria

  • Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • 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.

Criteria

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)

Contacts and Locations

Contacts

Contact: JiHyun Park, Regional Clinical Operations +82 2 3404 1490 Ji-Hyun.Park@bms.com

Contact: Keunyoung Kim, Regional Clinical Operations +82 2 3404 1450 Karen.kim@bms.com

Locations

Korea, Republic of
Hallym University Medical Center
Anyang

Korea, Republic of
Keimyung University Dongsan Hospital
Daegu

Korea, Republic of
Kyungpook National University Hospital
Daegu

Korea, Republic of
CHONNAM National University Hwasun Hospital
Hwasun

Korea, Republic of
Naitonal Health Insurance Service Ilsan hospital
Ilsan

Korea, Republic of
Gachon University Gil Mdical Center
Incheon

Korea, Republic of
Jeonbuk National University Hospital
JeonJu

Korea, Republic of
Seoul National University Hospital
Seoul

Korea, Republic of
Yonsei University Severance Hospital
Seoul

Korea, Republic of
Asan Medical Center
Seoul

Korea, Republic of
Samsung Medical Center
Seoul

Korea, Republic of
The Catholic University, St. Mary's Hospital
Seoul

Korea, Republic of
Wonju Severance Christian Hospital
Wonju

Sponsors and Collaborators

Celgene

Investigators

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

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT04036448 History of Changes
  • Other Study ID Numbers: CC-5013-MDS-013, U1111-1235-2858
  • First Posted: July 29, 2019 Key Record Dates
  • Last Update Posted: April 8, 2021
  • Last Verified: March 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • 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/
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
  • Time Frame: See Plan Description
  • Access Criteria: See Plan Description
  • URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: REVLIMID®
    Lenalidomide
    Observational
    Post Marketing Surveillance[PMS]
    Relapsed and Refractory Mantle cell lymphoma
    Korea
    IPSS Low- or intermediate-1-risk Myelodysplastic Syndromes Associated with a deletion 5q
    previously treated follicular lymphoma (FL) in Korea
  • Additional relevant MeSH terms: Lymphoma
    Preleukemia
    Lymphoma, Mantle-Cell
    Lymphoma, Follicular
    Myelodysplastic Syndromes
    Syndrome