RevlimidPMS: 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

• Sponsor: Celgene (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04036448
• Collaborator: (none)
• Enrollment: 600
• Locations: 13
• Anticipated Duration (Months): 33.4
• Patients Per Site: 46.2
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes; Lymphoma, Mantle-Cell; Lymphoma, Follicular	Drug: REVLIMID®

Study Design

• Study Type: Observational
• Anticipated Enrollment: 600 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Aug 18, 2019
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Lenalidomide in IPSS Low-or intermediate-1-risk del population 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®; REVLIMID®
Lenalidomide in Refractory/relapsed rrMC/ Follicular lymphoma population 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®; REVLIMID®

Outcome Measures

Primary Outcome Measures

1. Adverse events (AEs) [From enrollment until at least 28 days after completion of study treatment]

   Number of participants with adverse event

Secondary Outcome Measures

1. Adverse events (AEs) [From enrollment until at least 28 days after completion of study treatment]

   Number of participants with adverse events

2. To evaluate the effectiveness of REVLIMID® treatment in patients with IPSS low- or intermediate-1-risk del (5q) MDS [Up to 4 years of Revlimid treatment period]

   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

3. To evaluate the effectiveness of REVLIMID® treatment in patients with rrMCL [Up to 4 years of Revlimid treatment period]

   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

4. To evaluate the effectiveness of REVLIMID® treatment in patients with previously treated FL [Up to 4 years of Revlimid treatment period]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hallym University Medical Center	Anyang		Korea, Republic of	14068
2	Keimyung University Dongsan Hospital	Daegu		Korea, Republic of	41931
3	Kyungpook National University Hospital	Daegu		Korea, Republic of	41944
4	CHONNAM National University Hwasun Hospital	Hwasun		Korea, Republic of	58128
5	Naitonal Health Insurance Service Ilsan hospital	Ilsan		Korea, Republic of	10444
6	Gachon University Gil Mdical Center	Incheon		Korea, Republic of	21565
7	Jeonbuk National University Hospital	JeonJu		Korea, Republic of	54896
8	Seoul National University Hospital	Seoul		Korea, Republic of	03080
9	Yonsei University Severance Hospital	Seoul		Korea, Republic of	03722
10	Asan Medical Center	Seoul		Korea, Republic of	05505
11	Samsung Medical Center	Seoul		Korea, Republic of	06351
12	The Catholic University, St. Mary's Hospital	Seoul		Korea, Republic of	06591
13	Wonju Severance Christian Hospital	Wonju		Korea, Republic of	26426

Sponsors and Collaborators

• Celgene

Investigators

• Study Director: Claire (Myoung-Jin) Lee, Medical doctor, Celgene Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT04036448
• Other Study ID Numbers: CC-5013-MDS-013; U1111-1235-2858
• First Posted: Jul 29, 2019
• Last Update Posted: Apr 8, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Celgene: 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
• Additional relevant MeSH terms: Lymphoma; Preleukemia; Lymphoma, Mantle-Cell; Lymphoma, Follicular; Myelodysplastic Syndromes; Syndrome; Lenalidomide

Study Results

No Results Posted as of Apr 8, 2021