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

Velcade - Regulatory Post Marketing Surveillance (PMS)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01005628

Enrollment

1121

Registered

2009-11-02

Start date

2006-06-30

Completion date

2012-03-31

Last updated

2013-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Bortezomib postmarketing surveillance, Korea bortezomib PMS

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

Interventions

DRUGbortezomib

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026