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

Celgene28 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

Conditions

Myelodysplastic Syndromes Lymphoma, Mantle-Cell Lymphoma, Follicular

Interventions

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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)

Locations (26)

Local Institution - S02

Seoul, Seoul Teugbyeolsi, South Korea

Hallym University Medical Center

Anyang, South Korea

Keimyung University Dongsan Hospital

Daegu, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Local Institution - S03

Daegu, South Korea

Local Institution - S07

Daegu, South Korea

Local Institution - S11

Goyang, South Korea

CHONNAM National University Hwasun Hospital

Hwasun, South Korea

Local Institution - S04

Hwasun-gun, South Korea

Naitonal Health Insurance Service Ilsan hospital

Ilsan, South Korea

...and 16 more locations

Outcomes

Primary Outcomes

Adverse events (AEs)

Number of participants with adverse event

Time frame: From enrollment until at least 28 days after completion of study treatment

Secondary Outcomes

Adverse events (AEs)

Number of participants with adverse events

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: Up to 4 years of Revlimid treatment period