Clinical Trials Directory

Trials / Completed

CompletedNCT03288974

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

Status
Completed
Phase
Study type
Observational
Enrollment
397 (actual)
Sponsor
Celgene · Industry
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
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

Timeline

Start date
2017-12-28
Primary completion
2023-11-16
Completion
2023-11-16
First posted
2017-09-20
Last updated
2025-04-15

Locations

33 sites across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03288974. Inclusion in this directory is not an endorsement.