Multiple Myeloma Clinical Trial
Official title:
REVLIMID® Drug Use Examination
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.
n/a
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