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

Celgene

Status: Completed

Conditions: Multiple Myeloma

Treatments: Drug: Dexamethasone; Drug: REVLIMID®

Study type: Observational

Funder types: Industry

Identifiers

NCT02556905

NIPMS-RV-KR-001

Details and patient eligibility

About

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.

Enrollment: 624 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

624 participants in 1 patient group

Korean patients

Description:

All Korean patients intended to be treated with REVLIMID® according to the approved package insert

Treatment:

Drug: REVLIMID®

Drug: Dexamethasone