Post Marketing Surveillance on Safety Evaluation of POMALYST® (Pomalidomide) Treatment of Multiple Myeloma in Korea
Pomalyst PMS
2 other identifiers
observational
397
1 country
33
Brief Summary
PMS period: 09Jun2017 \~ 08Jun2023 Target no.: 600patients 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2017
Longer than P75 for all trials
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2017
CompletedFirst Posted
Study publicly available on registry
September 20, 2017
CompletedStudy Start
First participant enrolled
December 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2023
CompletedApril 15, 2025
April 1, 2025
5.9 years
September 5, 2017
April 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events
Any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment, i.e., any unfavorable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.se temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
From enrollment until at least 28 days after completion of study treatment
Secondary Outcomes (1)
Overall response rate
Up to approximately 5.6 months
Study Arms (1)
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.
Interventions
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
Patients who are treated with POMALYST® based on the following criteria, can be registered into this DUE. •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.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (33)
Korea University Ansan Hospital
Ansan, 15355, South Korea
Hallym University Sacred Heart Hospital
Anyang, 14068, South Korea
Soonchunhyang University Hospital
Bucheon-si, 14584, South Korea
Inje University Busan Paik Hospital
Busan, 47932, South Korea
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Dong-A University Hospital
Busan, 49201, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Kosin University Gospel Hospital
Busan, 49267, South Korea
Keimyung University Dongsan Medical
Daegu, 41931, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Daegu Catholic University Medical Center
Daegu, 42472, South Korea
Local Institution - 021
Daegu, 42472, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Chonnam National University Hwasun Hospital
Hwasun, 58128, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Chonbuk National University Hospital
Jeonju, 54907, South Korea
Gyeongsang National University Hospital
Jinju, 52727, South Korea
Local Institution - 024
Jinju, 660-702, South Korea
Inje University Sanggye Paik Hospital
Seoul, 01757, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The catholic University of Korea Seoul St. Maty's
Seoul, 06591, South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 07061, South Korea
Ewha Womans University Medical
Seoul, 07985, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Local Institution - 001
Seoul, 135-710, South Korea
Local Institution - 002
Seoul, 136-705, South Korea
Ajou Unversity Medical Center
Suwon, 16499, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
Pusan National University Yangsan
Yangsan, 50612, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2017
First Posted
September 20, 2017
Study Start
December 28, 2017
Primary Completion
November 16, 2023
Study Completion
November 16, 2023
Last Updated
April 15, 2025
Record last verified: 2025-04