Post Marketing Surveillance on Safety Evaluation of POMALYST® (Pomalidomide) Treatment of Multiple Myeloma in Korea
NCT ID: NCT03288974
Last Updated: 2025-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
397 participants
OBSERVATIONAL
2017-12-28
2023-11-16
Brief Summary
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indication: POMALYST in combination with dexamethasone is indicated in the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib
The primary objective of this Drug Use Examination (DUE) is to evaluate safety of POMALYST® (Pomalidomide) treatment of multiple myeloma in the clinical routine practice in Korea.
The secondary objective of this DUE is to evaluate effectiveness of POMALYST® (Pomalidomide) treatment of multiple myeloma in the clinical routine practice in Korea.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Post Marketing Survey of MM patients treated with POMALYST®
As a method of POMALYST® PMS, Drug Use Examination (DUE) is planned and designed to comply with the regulatory requirement in consequence of approval of a new drug in Korea. This DUE is a non-interventional, observational and post-marketing surveillance, which is conducted as a regulatory required procedure to evaluate product safety of a new drug treatment in clinical routine practice in Korea. And this DUE will be conducted in compliance with the local guideline \[standard for Re-examination of New Drugs, etc.\] as a post approval commitment.
POMALYST® (Pomalidomide)
The recommended starting dose of POMALYST is 4 mg once daily taken orally on Days 1 to 21 of repeated 28-day cycles. The recommended dose of dexamethasone is 40 mg orally once daily on Days 1, 8, 15 and 22 of each 28-day treatment cycle
Interventions
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POMALYST® (Pomalidomide)
The recommended starting dose of POMALYST is 4 mg once daily taken orally on Days 1 to 21 of repeated 28-day cycles. The recommended dose of dexamethasone is 40 mg orally once daily on Days 1, 8, 15 and 22 of each 28-day treatment cycle
Eligibility Criteria
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Inclusion Criteria
* POMALYST® in combination with dexamethasone is indicated in the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib.
19 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Korea University Ansan Hospital
Ansan, , South Korea
Hallym University Sacred Heart Hospital
Anyang, , South Korea
Soonchunhyang University Hospital
Bucheon-si, , South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
Dong-A University Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Kosin University Gospel Hospital
Busan, , South Korea
Keimyung University Dongsan Medical
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Local Institution - 021
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Inha University Hospital
Incheon, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Gyeongsang National University Hospital
Jinju, , South Korea
Local Institution - 024
Jinju, , South Korea
Inje University Sanggye Paik Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The catholic University of Korea Seoul St. Maty's
Seoul, , South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, , South Korea
Ewha Womans University Medical
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Local Institution - 001
Seoul, , South Korea
Local Institution - 002
Seoul, , South Korea
Ajou Unversity Medical Center
Suwon, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Wonju Severance Christian Hospital
Wŏnju, , South Korea
Pusan National University Yangsan
Yangsan, , South Korea
Countries
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Other Identifiers
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U1111-1201-1712
Identifier Type: REGISTRY
Identifier Source: secondary_id
NIPMS-POM-KR-001
Identifier Type: -
Identifier Source: org_study_id
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