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Velcade - Regulatory Post Marketing Surveillance (PMS)

Phase 4
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

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

Inclusion Criteria:

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

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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

The data on AE (Adverse event) incidence, such as whether AEs occurred, types of AEs, and incidence of AEs by type

Outcome Time Frame:

every cycles or every 3 weeks

Safety Issue:


Principal Investigator

Janssen Korea, Ltd. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Korea, Ltd.


Korea: Food and Drug Administration

Study ID:




Start Date:

June 2006

Completion Date:

March 2012

Related Keywords:

  • Multiple Myeloma
  • Bortezomib postmarketing surveillance
  • Korea bortezomib PMS
  • Multiple Myeloma
  • Neoplasms, Plasma Cell