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

Study Overview
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Brief Summary
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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. 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) Patients with mantle cell lymphoma who have received at least one prior therapy (rrMCL) Previously treated follicular lymphoma (FL), in combination with rituximab (an anti-CD20 antibody)

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

Conditions
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Myelodysplastic Syndromes, Lymphoma, Mantle-Cell, Lymphoma, Follicular

Intervention / Treatment
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* Drug: REVLIMID®


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lenalidomide in IPSS Low-or intermediate-1-risk del population<br>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®<br>* REVLIMID®<br>|
| Lenalidomide in Refractory/relapsed rrMC/ Follicular lymphoma population<br>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®<br>* REVLIMID®<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) | 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) | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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, previously treated follicular lymphoma (FL) in Korea