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

Celgene397 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

397

Conditions

Multiple Myeloma

Interventions

POMALYST® (Pomalidomide)DRUG

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

Medical Language ↔ Plain English

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

Locations (33)

Korea University Ansan Hospital

Ansan, South Korea

Hallym University Sacred Heart Hospital

Anyang, South Korea

Soonchunhyang University Hospital

Bucheon-si, South Korea

Inje University Busan Paik Hospital

Busan, South Korea

Inje University Haeundae Paik Hospital

Busan, South Korea

Dong-A University Hospital

Outcomes

Primary Outcomes

Adverse events

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.

Time frame: From enrollment until at least 28 days after completion of study treatment

Secondary Outcomes

Overall response rate

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.

Time frame: Up to approximately 5.6 months