Clinical trial · Observational
Post Marketing Surveillance on Safety Evaluation of POMALYST® (Pomalidomide) Treatment of Multiple Myeloma in Korea
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| POMALYST® (Pomalidomide) | Drug | Pomalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Post Marketing Survey of MM patients treated with POMALYST®
- description
- 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.
- interventionNames
- Drug: POMALYST® (Pomalidomide)
Primary outcomes (1)
- measure
- Adverse events
- timeFrame
- From enrollment until at least 28 days after completion of study treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
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