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Trial record 21 of 895 for:    LENALIDOMIDE

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)

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ClinicalTrials.gov Identifier: NCT04036448
Recruitment Status : Not yet recruiting
First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

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)

Condition or disease Intervention/treatment
Myelodysplastic Syndromes Lymphoma, Mantle-Cell Drug: REVLIMID®

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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 IPSS Low- or Intermediate-1-risk Myelodysplastic Syndromes Associated With a Deletion 5q or Refractory/Relapsed Mantle Cell Lymphoma in Korea
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022


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 rrMCL 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.
Drug: REVLIMID®
REVLIMID®




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: 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



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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 and rrMCL.
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
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04036448


Contacts
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Contact: JiHyun Park, Medical Affairs +82 2 3469-7837 jhpark@celgene.com
Contact: Keunyoung Kim, Medical Affairs +82 2 3469 7962 kakim@celgene.com

Sponsors and Collaborators
Celgene
Investigators
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Study Director: Claire (Myoung-Jin) Lee, Medical doctor Celgene Korea

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04036448     History of Changes
Other Study ID Numbers: CC-5013-MDS-013
U1111-1235-2858 ( Other Identifier: WHO )
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
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/

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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
Korea
Post Marketing Surveillance[PMS]
Relapsed and Refractory Mantle cell lymphoma
IPSS Low- or intermediate-1-risk Myelodysplastic Syndromes Associated with a deletion 5q
Additional relevant MeSH terms:
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Lenalidomide
Lymphoma
Preleukemia
Lymphoma, Mantle-Cell
Myelodysplastic Syndromes
Syndrome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoma, Non-Hodgkin
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents