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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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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
Show Show 25 study locations
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Miran Moon Celgene Korea
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02556905    
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:
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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
Lenalidomide
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
Immunologic Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents