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

Celgene

Status: Completed

Conditions: Multiple Myeloma

Treatments: Drug: POMALYST® (Pomalidomide)

Study type: Observational

Funder types: Industry

Identifiers

NCT03288974

U1111-1201-1712 (Registry Identifier)

NIPMS-POM-KR-001

Details and patient eligibility

About

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.

Enrollment: 397 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

397 participants in 1 patient group

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.

Treatment:

Drug: POMALYST® (Pomalidomide)