Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| REVLIMID® | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Korean patients
- description
- All Korean patients intended to be treated with REVLIMID® according to the approved package insert
- interventionNames
- Drug: REVLIMID®
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Adverse events (AEs)
- timeFrame
- Up to 6 years
- description
- Number of participants with adverse events
Secondary outcomes (1)
- measure
- Overall response rate
- timeFrame
- Up to 6 years
- description
- Number of participants with response based on International Myeloma Working Group Criteria for Multiple Myeloma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available