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

November 30, 2017 updated by: Celgene

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

624

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Anyang, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital
      • Bucheon, Korea, Republic of, 14584
        • Soon Chun Hyang University Hospital Bucheon
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital
      • Busan, Korea, Republic of, 47392
        • Inje University Busan Paik Hospital
      • Busan, Korea, Republic of, 49267
        • Kosin University Gospel Hospital
      • Busan, Korea, Republic of, 49201
        • Dong-A University Medical Center
      • Daegu, Korea, Republic of, 41954
        • Kyungpook National University Hospital
      • Daejeon, Korea, Republic of, 35015
        • Chungnam National University Hospital
      • Hwasun-gun, Korea, Republic of, 58128
        • Hwasun Chonnam National University Hospital
      • Jeonju, Korea, Republic of, 54907
        • Chonbuk National University Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea, Seoul ST. Mary's Hospital
      • Seoul, Korea, Republic of, 07985
        • EWHA Womans University Mokdong Hospital
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 01757
        • Inje University Sanggye Paik Hospital
      • Seoul, Korea, Republic of, 05030
        • Konkuk University Hospital
      • Seoul, Korea, Republic of, 07061
        • Boramae Medical Center
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hospital
      • Wonju, Korea, Republic of, 26426
        • Wonju Severance Christian Hospital
      • Yangsan, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All Korean patients who are intended to be treated with REVLIMID® and must be registered in risk management program according to the approved package insert.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Korean patients
All Korean patients intended to be treated with REVLIMID® according to the approved package insert
Drug: REVLIMID®
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.
Drug: Dexamethasone
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate
Time Frame: Up to 6 years
Number of participants with response based on International Myeloma Working Group Criteria for Multiple Myeloma
Up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Miran Moon, Celgene Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2011

Primary Completion (Actual)

November 30, 2016

Study Completion (Actual)

November 30, 2016

Study Registration Dates

First Submitted

September 21, 2015

First Submitted That Met QC Criteria

September 21, 2015

First Posted (Estimate)

September 22, 2015

Study Record Updates

Last Update Posted (Actual)

December 4, 2017

Last Update Submitted That Met QC Criteria

November 30, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIPMS-RV-KR-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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