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

Study Overview
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Brief Summary
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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.

Official Title
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REVLIMID® Drug Use Examination

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: REVLIMID®
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: There's no exclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Korean patients<br>All Korean patients intended to be treated with REVLIMID® according to the approved package insert | Drug: REVLIMID®<br>* 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.<br>Drug: Dexamethasone<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) | Number of participants with adverse events | Up to 6 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, Revlimid, Lenalidomide, Observational, Korea, Post Marketing Surveillance[PMS]