Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, POMALYST®, Pomalidomide, Observational, Korea, Post Marketing Surveillance[PMS], Relapsed and Refractory Multiple Myeloma
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.
Interventions
DRUGPOMALYST® (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
Sponsors
Celgene
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | 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. |
Countries
South Korea
Outcome results
None listed