Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Syndrome

Lymphoma

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Preleukemia

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Lymphoma, Non-Hodgkin

Lymphosarcoma

Mantle Cell Lymphoma

Follicular Lymphoma

Chromosome 5q Deletion

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Lenalidomide

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

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.

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.

REVLIMID®

Claire (Myoung-Jin) Lee, Medical doctor

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)

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

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

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/

Number of participants with adverse event

Number of participants with adverse events

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

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

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.

Celgene

Spots Global Cancer Trial Database for relapsed and refractory mantle cell lymphoma