Multiple Myeloma Clinical Trial
— Pomalyst PMSOfficial title:
Post Marketing Surveillance on Safety Evaluation of POMALYST® (Pomalidomide) Treatment of Multiple Myeloma in Korea
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.
| Status | Recruiting |
| Enrollment | 600 |
| Est. completion date | June 8, 2024 |
| Est. primary completion date | June 8, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility | Inclusion Criteria: 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. Exclusion Criteria: - There's no exclusion criteria |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Korea University Ansan Hospital | Ansan | |
| Korea, Republic of | Hallym University Sacred Heart Hospital | Anyang | |
| Korea, Republic of | Soonchunhyang University Hospital | Bucheon | |
| Korea, Republic of | Dong-A University Hospital | Busan | |
| Korea, Republic of | Inje University Busan Paik Hospital | Busan | |
| Korea, Republic of | Inje University Haeundae Paik Hospital | Busan | |
| Korea, Republic of | Kosin University Gospel Hospital | Busan | |
| Korea, Republic of | Pusan National University Hospital | Busan | |
| Korea, Republic of | Daegu Catholic University Medical Center | Daegu | |
| Korea, Republic of | Keimyung University Dongsan Medical | Daegu | |
| Korea, Republic of | Local Institution - 021 | Daegu | |
| Korea, Republic of | Yeungnam University Medical Center | Daegu | |
| Korea, Republic of | Chungnam National University Hospital | DaeJeon | |
| 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 | Ewha Womans University Medical | Seoul | |
| Korea, Republic of | Inje University Sanggye Paik Hospital | Seoul | |
| Korea, Republic of | Korea University Anam Hospital | 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 | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul Metropolitan Government Seoul National University Boramae Medical Center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Severance Hospital | Seoul | |
| Korea, Republic of | The catholic University of Korea Seoul St. Maty's | Seoul | |
| Korea, Republic of | Ajou Unversity Medical Center | Suwon | |
| Korea, Republic of | Ulsan University Hospital | Ulsan | |
| Korea, Republic of | Wonju Severance Christian Hospital | Wonju | |
| Korea, Republic of | Pusan National University Yangsan | Yangsan |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Overall response rate | 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. |
Up to approximately 5.6 months |
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