A Study to Collect and Evaluate the Safety and Efficacy Information of Korean Multiple Myeloma Patients Treated With REVLIMID®, After Approval of Marketing Authorization for New Drug in Korea
NCT ID: NCT02556905
Last Updated: 2017-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
624 participants
OBSERVATIONAL
2011-03-09
2016-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Korean patients
All Korean patients intended to be treated with REVLIMID® according to the approved package insert
REVLIMID®
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.
Dexamethasone
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.
Interventions
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REVLIMID®
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.
Dexamethasone
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.
Eligibility Criteria
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Inclusion Criteria
* In-patients or out patients during the REVLIMID® Drug Use Examination period who are intended to be treated with REVLIMID ®
* Patients who are registered for Risk Management Program of Celgene
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Miran Moon
Role: STUDY_DIRECTOR
Celgene Korea
Locations
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Hallym University Sacred Heart Hospital
Anyang, , South Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, , South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
Dong-a University Medical Center
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Kosin University Gospel Hospital
Busan, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Hwasun Chonnam National University Hospital
Hwasun-gun, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Inje University Sanggye Paik Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Konkuk University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Boramae Medical Center
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Wonju Severance Christian Hospital
Wŏnju, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Countries
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Other Identifiers
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NIPMS-RV-KR-001
Identifier Type: -
Identifier Source: org_study_id