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NCT Number: NCT04036448

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

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)

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Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - S02, Seoul, Seoul Teugbyeolsi, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

REVLIMID®

Drug

REVLIMID®

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study 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

Acronym: RevlimidPMS

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 29, 2019
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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