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

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: bortezomib

• Registration Number: NCT01005628
• Lead Sponsor: Janssen Korea, Ltd., Korea

Brief 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).

Detailed 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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-10-29
• Study First Posted: 2009-11-01
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-18
• Last Update Posted: 2013-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1121

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
001	bortezomib	bortezomib Injection into a vein 1.3 mg/m2 twice a week for 21 days

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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