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

April 14, 2025 updated by: Celgene

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

397

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Ansan, Korea, Republic of, 15355
        • Korea University Ansan Hospital
      • Anyang, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital
      • Bucheon, Korea, Republic of, 14584
        • Soonchunhyang University Hospital
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 48108
        • Inje university Haeundae Paik Hospital
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital
      • Busan, Korea, Republic of, 49267
        • Kosin University Gospel Hospital
      • Busan, Korea, Republic of, 47932
        • Inje University Busan Paik Hospital
      • DaeJeon, Korea, Republic of, 35015
        • Chungnam National University Hospital
      • Daegu, Korea, Republic of, 42415
        • Yeungnam University Medical Center
      • Daegu, Korea, Republic of, 42472
        • Daegu Catholic University Medical Center
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Medical
      • Daegu, Korea, Republic of, 42472
        • Local Institution - 021
      • Hwasun, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Jeonju, Korea, Republic of, 54907
        • Chonbuk National University Hospital
      • JinJu, Korea, Republic of, 52727
        • Gyeongsang National University Hospital
      • Jinju, Korea, Republic of, 660-702
        • Local Institution - 024
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 07061
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 01757
        • Inje University Sanggye Paik Hospital
      • Seoul, Korea, Republic of, 06591
        • The catholic University of Korea Seoul St. Maty's
      • Seoul, Korea, Republic of, 07985
        • Ewha Womans University Medical
      • Seoul, Korea, Republic of, 135-710
        • Local Institution - 001
      • Seoul, Korea, Republic of, 136-705
        • Local Institution - 002
      • Suwon, Korea, Republic of, 16499
        • Ajou Unversity Medical Center
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hospital
      • Wonju, Korea, Republic of, 26426
        • Wonju Severance Christian Hospital
      • Yangsan, Korea, Republic of, 50612
        • Pusan National University Yangsan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment until at least 28 days after completion of study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 5.6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2017

Primary Completion (Actual)

November 16, 2023

Study Completion (Actual)

November 16, 2023

Study Registration Dates

First Submitted

September 5, 2017

First Submitted That Met QC Criteria

September 18, 2017

First Posted (Actual)

September 20, 2017

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIPMS-POM-KR-001
  • U1111-1201-1712 (Registry Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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