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

Multiple Myeloma Clinical Trial

Official title:

Velcade - Regulatory Post Marketing Surveillance (PMS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01005628
• Other study ID #: CR012958
• Secondary ID: bortezomib PMS
• Status: Completed
• Phase: Phase 4
• First received: October 29, 2009
• Last updated: February 18, 2013
• Start date: June 2006
• Est. completion date: March 2012

Study information

• Verified date: February 2013
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationRepublic of Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1121
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Myeloma

Intervention

Drug:
• bortezomib
Injection into a vein 1.3 mg/m2 twice a week for 21 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	The overall response rate (complete remission rate+partal remission rate) will be measured according to the EBMT or IMWG criteria.		every cycle or every 3 weeks and end of treatment	No