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The main purpose of REVLIMID® DUE (Drug Use Examination) is to collect and evaluate the safety information of Korean Multiple Myeloma patients treated with REVLIMID® according to the approved package insert, after approval of marketing authorization for new drug in Korea. In addition, the efficacy information of REVLIMID® in clinical practice is collected and evaluated. This DUE is a multi-centre, observational and non-interventional post-marketing surveillance.
The patients can be recruited through both Drug Use Examination after the initiation of Post Marketing Surveillance(contract with institution) and Patient Access Program(PAP) that was performed before REVLIMID® reimbursement.
Total 624 patient has enrolled in PMS by 07Sep2016. Validation process for eligibility for safety assessment has been conducted by site monitoring process by 07Dec2016.
REVLIMID® DUE is to investigate frequency and change of Adverse Events(AEs) /Adverse Drug Reactions(ADRs), Serious Adverse Events(SAEs)/Serious Adverse Drug Reactions(SADRs), unexpected AE/ADR and unexpected SAE/SADR, and to scrutinize factors influencing safety & efficacy of the drug.
It is necessary to examine patients' demographics and baseline characteristics, medical history, status of REVLIMID® treatment, concomitant medication and evaluation of safety and final efficacy (best response) assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Korean patients | All Korean patients intended to be treated with REVLIMID® according to the approved package insert |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REVLIMID® | Drug | The recommended starting dose of REVLIMID® is 25mg/day with water orally administered as a single 25mg capsule on Days 1-21 of repeated 28-day cycles. Dose can be adjusted upon the clinical laboratory result. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Number of participants with adverse events | Up to 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Number of participants with response based on International Myeloma Working Group Criteria for Multiple Myeloma | Up to 6 years |
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Inclusion Criteria:
Exclusion Criteria:
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All Korean patients who are intended to be treated with REVLIMID® and must be registered in risk management program according to the approved package insert.
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| Name | Affiliation | Role |
|---|---|---|
| Miran Moon | Celgene Korea | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang | 14068 | South Korea | |||
| Soon Chun Hyang University Hospital Bucheon |
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| Dexamethasone | Drug | The recommended dose of dexamethasone is 40mg/day on Days 1-4, 9-12, and 17-20 of each 28-day cycle for the 4 cycle of therapy and then 40mg/day orally on Days 1-4 every 28 days. |
|
| Bucheon-si |
| 14584 |
| South Korea |
| Inje University Busan Paik Hospital | Busan | 47392 | South Korea |
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
| Dong-a University Medical Center | Busan | 49201 | South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Kosin University Gospel Hospital | Busan | 49267 | South Korea |
| Kyungpook National University Hospital | Daegu | 41954 | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Hwasun Chonnam National University Hospital | Hwasun-gun | 58128 | South Korea |
| Chonbuk National University Hospital | Jeonju | 54907 | South Korea |
| Inje University Sanggye Paik Hospital | Seoul | 01757 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| Konkuk University Hospital | Seoul | 05030 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| Boramae Medical Center | Seoul | 07061 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 07985 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Ulsan University Hospital | Ulsan | 44033 | South Korea |
| Wonju Severance Christian Hospital | Wŏnju | 26426 | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | 50612 | South Korea |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| 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 |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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