Velcade - Regulatory Post Marketing Surveillance (PMS)
After the KFDA 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). We will collect
the response rate according to the EMBT (European Group for Blood and Marrow Transplant; a
non-profit organization based in the Netherlands that promotes the transplantation of
haemopoietic stem cells from all donor sources and donor types and related basic and
clinical research, education, standardization, quality control, and accreditation for
transplant procedures) or IMWG (the International Myeloma Working Group) criteria and the
adverse events to assess the efficacy and safety. Observational Study - No investigational
drug administered
Observational
Observational Model: Case-Only, Time Perspective: Prospective
The data on AE (Adverse event) incidence, such as whether AEs occurred, types of AEs, and incidence of AEs by type
every cycles or every 3 weeks
No
Janssen Korea, Ltd. Clinical Trial
Study Director
Janssen Korea, Ltd.
Korea: Food and Drug Administration
CR012958
NCT01005628
June 2006
March 2012
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