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

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).

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bortezomib

Drug

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

Primary outcomes

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

Time frame: every cycles or every 3 weeks

Secondary outcomes

The overall response rate (complete remission rate+partal remission rate) will be measured according to the EBMT or IMWG criteria.

Time frame: every cycle or every 3 weeks and end of treatment

Sponsors and collaborators

Lead sponsor

Janssen Korea, Ltd., Korea

Industry

Registry information

Official study title

Velcade - Regulatory Post Marketing Surveillance (PMS)

Important dates

Study start: 2006
Primary completion: 2012
Study completion: 2012
First posted: Nov 2, 2009
Registry last updated: Feb 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed