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

NCT ID: NCT01005628

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1121 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2012-03-31

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

Conditions

Multiple Myeloma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

001

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

bortezomib

Intervention Type: DRUG

Injection into a vein 1.3 mg/m2 twice a week for 21 days

Interventions

bortezomib

Injection into a vein 1.3 mg/m2 twice a week for 21 days

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Korea, Ltd. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd.

Locations

Seoul, , South Korea

Countries

South Korea

Other Identifiers

bortezomib PMS

Identifier Type: OTHER

Identifier Source: secondary_id

CR012958

Identifier Type: -

Identifier Source: org_study_id