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
|ClinicalTrials.gov Identifier: NCT02556905|
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : December 4, 2017
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.
|Condition or disease||Intervention/treatment|
|Multiple Myeloma||Drug: REVLIMID® Drug: Dexamethasone|
|Study Type :||Observational|
|Actual Enrollment :||624 participants|
|Official Title:||REVLIMID® Drug Use Examination|
|Actual Study Start Date :||March 9, 2011|
|Actual Primary Completion Date :||November 30, 2016|
|Actual Study Completion Date :||November 30, 2016|
All Korean patients intended to be treated with REVLIMID® according to the approved package insert
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.
- Adverse events (AEs) [ Time Frame: Up to 6 years ]Number of participants with adverse events
- Overall response rate [ Time Frame: Up to 6 years ]Number of participants with response based on International Myeloma Working Group Criteria for Multiple Myeloma
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556905
|Study Director:||Miran Moon||Celgene Korea|