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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1235-2858 | Other Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REVLIMID® | Drug | REVLIMID® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Number of participants with adverse event | From enrollment until at least 28 days after completion of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Number of participants with adverse events | From enrollment until at least 28 days after completion of study treatment |
| To evaluate the effectiveness of REVLIMID® treatment in patients with IPSS low- or intermediate-1-risk del (5q) MDS |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy or females of childbearing potential
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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 for IPSS low- or intermediate-1-risk del (5q) MDS, rrMCL and previously treated Follicular lymphoma.
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| Name | Affiliation | Role |
|---|---|---|
| Claire (Myoung-Jin) Lee, Medical doctor | Celgene Korea | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - S02 | Seoul | Seoul Teugbyeolsi | 05505 | South Korea | ||
| Hallym University Medical Center |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
See Plan Description
See Plan Description
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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 |
| 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 |
| 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 |
| Anyang |
| 14068 |
| South Korea |
| Keimyung University Dongsan Hospital | Daegu | 41931 | South Korea |
| Kyungpook National University Hospital | Daegu | 41944 | South Korea |
| Local Institution - S03 | Daegu | 700-712 | South Korea |
| Local Institution - S07 | Daegu | 700-721 | South Korea |
| Local Institution - S11 | Goyang | 411-719 | South Korea |
| CHONNAM National University Hwasun Hospital | Hwasun | 58128 | South Korea |
| Local Institution - S04 | Hwasun-gun | 519-809 | South Korea |
| Naitonal Health Insurance Service Ilsan hospital | Ilsan | 10444 | South Korea |
| Gachon University Gil Mdical Center | Incheon | 21565 | South Korea |
| Local Institution - S09 | Incheon | 21565 | South Korea |
| Jeonbuk National University Hospital | Jeonju | 54896 | South Korea |
| Local Institution - S10 | Jeonju | 54907 | South Korea |
| Local Institution - S05 | Seoul | 03080 | South Korea |
| Local Institution - S06 | Seoul | 03080 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Local Institution - S08 | Seoul | 03722 | South Korea |
| Yonsei University Severance Hospital | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Local Institution - S12 | Seoul | 06351 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Local Institution - S01 | Seoul | 06591 | South Korea |
| The Catholic University, St. Mary's Hospital | Seoul | 06591 | South Korea |
| Local Institution - S14 | Wŏnju | 26426 | South Korea |
| Wonju Severance Christian Hospital | Wŏnju | 26426 | South Korea |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D020522 | Lymphoma, Mantle-Cell |
| D008224 | Lymphoma, Follicular |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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