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Post Marketing Surveillance on Safety Evaluation of POMALYST® (Pomalidomide) Treatment of Multiple Myeloma in Korea (Pomalyst PMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03288974
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Multiple Myeloma Drug: POMALYST® (Pomalidomide)

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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
Study Population

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.

Criteria

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

Information from the National Library of Medicine

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


Contacts
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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

Locations
Show Show 29 study locations
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Claire Lee, Senior Medical Advisor Celgene Korea
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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
Keywords provided by Celgene:
Multiple Myeloma
POMALYST®
Pomalidomide
Observational
Korea
Post Marketing Surveillance[PMS]
Relapsed and Refractory Multiple Myeloma
Additional relevant MeSH terms:
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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