Post Marketing Surveillance on Safety Evaluation of POMALYST® (Pomalidomide) Treatment of Multiple Myeloma in Korea (Pomalyst PMS)
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| ClinicalTrials.gov Identifier: NCT03288974 |
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Recruitment Status :
Recruiting
First Posted : September 20, 2017
Last Update Posted : May 11, 2020
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Multiple Myeloma | Drug: POMALYST® (Pomalidomide) |
| Study Type : | Observational |
| Estimated Enrollment : | 600 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Post Marketing Surveillance on Safety Evaluation of POMALYST® (Pomalidomide) Treatment of Multiple Myeloma in Korea |
| Actual Study Start Date : | December 28, 2017 |
| Estimated Primary Completion Date : | June 8, 2023 |
| Estimated Study Completion Date : | June 8, 2023 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Drug: 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 |
- Adverse events [ Time Frame: 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.
- Overall response rate [ Time Frame: 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.
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| Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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
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): NCT03288974
| Contact: Karen Kim, Assoc. Mgr, Medical Affairs | +82 2 3469 7962 | kakim@celgene.com | |
| Contact: Ji-Hyun Park, Specialist, Medical Affairs | +82 2 3469 7837 | jhpark@celgene.com |
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| Study Director: | Claire Lee, Senior Medical Advisor | Celgene Korea |
| Responsible Party: | Celgene |
| ClinicalTrials.gov Identifier: | NCT03288974 |
| Other Study ID Numbers: |
NIPMS-POM-KR-001 U1111-1201-1712 ( Registry Identifier: WHO ) |
| First Posted: | September 20, 2017 Key Record Dates |
| Last Update Posted: | May 11, 2020 |
| Last Verified: | May 2020 |
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Multiple Myeloma POMALYST® Pomalidomide Observational |
Korea Post Marketing Surveillance[PMS] Relapsed and Refractory Multiple Myeloma |
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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 Pomalidomide Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |