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
REVLIMID® Drug Use Examination
1 other identifier
observational
624
1 country
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2011
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 9, 2011
CompletedFirst Submitted
Initial submission to the registry
September 21, 2015
CompletedFirst Posted
Study publicly available on registry
September 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2016
CompletedDecember 4, 2017
November 1, 2017
5.7 years
September 21, 2015
November 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events (AEs)
Number of participants with adverse events
Up to 6 years
Secondary Outcomes (1)
Overall response rate
Up to 6 years
Study Arms (1)
Korean patients
All Korean patients intended to be treated with REVLIMID® according to the approved package insert
Interventions
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.
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
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.
You may qualify if:
- Korean male or female who are diagnosed with Multiple Myeloma
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (25)
Hallym University Sacred Heart Hospital
Anyang, 14068, South Korea
Soon Chun Hyang University Hospital Bucheon
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Miran Moon
Celgene Korea
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2015
First Posted
September 22, 2015
Study Start
March 9, 2011
Primary Completion
November 30, 2016
Study Completion
November 30, 2016
Last Updated
December 4, 2017
Record last verified: 2017-11