Lymphoma, Follicular, Lymphoma, Mantle-Cell, Myelodysplastic Syndromes
Conditions
Keywords
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
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)
Interventions
DRUGREVLIMID®
REVLIMID®
Sponsors
Celgene
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | From enrollment until at least 28 days after completion of study treatment | Number of participants with adverse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | 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 | 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 | 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 |
| 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. |
Countries
South Korea
Outcome results
None listed