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

Myelodysplastic Syndromes Clinical Trial

— RevlimidPMS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04036448
• Other study ID #: CC-5013-MDS-013
• Secondary ID: U1111-1235-2858
• Status: Completed
• Start date: August 18, 2019
• Est. completion date: August 15, 2023

Study information

• Verified date: January 2024
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Mantle-Cell
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• REVLIMID®
REVLIMID®

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Medical Center	Anyang
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Local Institution - S03	Daegu
Korea, Republic of	Local Institution - S07	Daegu
Korea, Republic of	Local Institution - S11	Goyang
Korea, Republic of	CHONNAM National University Hwasun Hospital	Hwasun
Korea, Republic of	Local Institution - S04	Hwasun-gun
Korea, Republic of	Naitonal Health Insurance Service Ilsan hospital	Ilsan
Korea, Republic of	Gachon University Gil Mdical Center	Incheon
Korea, Republic of	Local Institution - S09	Incheon
Korea, Republic of	Jeonbuk National University Hospital	JeonJu
Korea, Republic of	Local Institution - S10	Jeonju-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Local Institution - S01	Seoul
Korea, Republic of	Local Institution - S05	Seoul
Korea, Republic of	Local Institution - S06	Seoul
Korea, Republic of	Local Institution - S08	Seoul
Korea, Republic of	Local Institution - S12	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	The Catholic University, St. Mary's Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul
Korea, Republic of	Local Institution - S02	Seoul-si	Seoul Teugbyeolsi
Korea, Republic of	Local Institution - S14	Wonju
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AEs)	Number of participants with adverse event	From enrollment until at least 28 days after completion of study treatment
Secondary	Adverse events (AEs)	Number of participants with adverse events	From enrollment until at least 28 days after completion of study treatment
Secondary	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
Secondary	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
Secondary	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

External Links

•   BMS Clinical Trial Information