Overview

Bortezomib (Velcade) - Regulatory Post Marketing Surveillance (PMS)

Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
0
Participant gender:
All
Summary
After the KFDA (Korea Food and Drug Administration) approval of a new drug, an annual report of the drug's safety and efficacy data must be reported to the Health Authority in 6 years. In this Observational study, we will investigate the basic demographic, medical history, concomitant drug use, as well as dosing information of multiple myeloma patients using bortezomib (Velcade).
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Korea, Ltd., Korea
Treatments:
Bortezomib
Criteria
Inclusion Criteria:

- Patients who are newly prescribed bortezomib injection for the treatment of multiple
myeloma

Exclusion Criteria:

- Patients who are hypersensitive to the bortezomib or any component of the bortezomib
or with a history of the hypersensitivity

- Patients with severe hepatic impairment

- Pregnant women