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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

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ClinicalTrials.gov Identifier: NCT02556905
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:

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.


Condition or disease Intervention/treatment
Multiple Myeloma Drug: REVLIMID® Drug: Dexamethasone

Study Type : Observational
Actual Enrollment : 624 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: REVLIMID® Drug Use Examination
Actual Study Start Date : March 9, 2011
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : November 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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.




Primary Outcome Measures :
  1. Adverse events (AEs) [ Time Frame: Up to 6 years ]
    Number of participants with adverse events


Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: Up to 6 years ]
    Number of participants with response based on International Myeloma Working Group Criteria for Multiple Myeloma



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556905


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

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02556905     History of Changes
Other Study ID Numbers: NIPMS-RV-KR-001
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017

Keywords provided by Celgene:
Multiple Myeloma
Revlimid
Lenalidomide
Observational
Korea
Post Marketing Surveillance[PMS]

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Lenalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents