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)

Celgene

Status: Completed

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

Treatments: Drug: REVLIMID®

Study type: Observational

Funder types: Industry

Identifiers

NCT04036448

U1111-1235-2858 (Other Identifier)

CC-5013-MDS-013

Details and patient eligibility

About

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)

Enrollment: 28 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

28 participants in 2 patient groups

Lenalidomide in IPSS Low-or intermediate-1-risk del population

Description:

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.

Treatment:

Drug: REVLIMID®

Lenalidomide in Refractory/relapsed rrMC/ Follicular lymphoma population

Description:

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.

Treatment:

Drug: REVLIMID®