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)
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|ClinicalTrials.gov Identifier: NCT04036448|
Recruitment Status : Not yet recruiting
First Posted : July 29, 2019
Last Update Posted : July 29, 2019
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)
|Condition or disease||Intervention/treatment|
|Myelodysplastic Syndromes Lymphoma, Mantle-Cell||Drug: REVLIMID®|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||Post Marketing Surveillance on Safety Evaluation 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|
|Estimated Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||June 1, 2022|
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.
Lenalidomide in Refractory/relapsed rrMCL 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.
- Adverse events (AEs) [ Time Frame: From enrollment until at least 28 days after completion of study treatment ]Number of participants with adverse event
- Adverse events (AEs) [ Time Frame: From enrollment until at least 28 days after completion of study treatment ]Number of participants with adverse events
- To evaluate the effectiveness of REVLIMID® treatment in patients with IPSS low- or intermediate-1-risk del (5q) MDS [ Time Frame: 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
- To evaluate the effectiveness of REVLIMID® treatment in patients with rrMCL [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04036448
|Contact: JiHyun Park, Medical Affairs||+82 2 firstname.lastname@example.org|
|Contact: Keunyoung Kim, Medical Affairs||+82 2 3469 email@example.com|
|Study Director:||Claire (Myoung-Jin) Lee, Medical doctor||Celgene Korea|