Post Marketing Surveillance on Safety Evaluation of POMALYST® (Pomalidomide) Treatment of Multiple Myeloma in Korea
- Registration Number
- NCT03288974
- Lead Sponsor
- Celgene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 397
The main criteria for inclusion of this DUE is the same as the approved package insert of POMALYST® in Korea. Based on the current PI, 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.
The actual inclusion criteria and patient population who can start with POMALYST® treatment will be narrowed down according to the local health insurance reimbursement condition.
- There's no exclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Post Marketing Survey of MM patients treated with POMALYST® POMALYST® (Pomalidomide) 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.
- Primary Outcome Measures
Name Time Method Adverse events From enrollment until at least 28 days after completion of study treatment 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.
- Secondary Outcome Measures
Name Time Method Overall response rate Up to approximately 5.6 months The percentage of patients who achieve CR (complete response), sCR (stringent complete response), Immunophenotypic CR, Molecular CR, VGPR (very good partial response) and PR (partial response) will be evaluated as overall response rate during POMALYST® treatment period based on International Myeloma Working Group Criteria for Multiple Myeloma.
Analysis and reporting for efficacy will be done at every 6months for the first 2years and after then, annual report(3,4,5th yearly report) and CSR for all data of 6years will be submitted to MFDS in accordance with MFDS guideline.
Trial Locations
- Locations (33)
Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Chungnam National University Hospital
🇰🇷DaeJeon, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Keimyung University Dongsan Medical
🇰🇷Daegu, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Soonchunhyang University Hospital
🇰🇷Bucheon, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Local Institution - 021
🇰🇷Daegu, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷JinJu, Korea, Republic of
Local Institution - 024
🇰🇷Jinju, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Inje University Sanggye Paik Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wonju, Korea, Republic of
Pusan National University Yangsan
🇰🇷Yangsan, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
The catholic University of Korea Seoul St. Maty's
🇰🇷Seoul, Korea, Republic of
Seoul Metropolitan Government Seoul National University Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Medical
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Local Institution - 001
🇰🇷Seoul, Korea, Republic of
Local Institution - 002
🇰🇷Seoul, Korea, Republic of
Ajou Unversity Medical Center
🇰🇷Suwon, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of