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

February 18, 2013 updated by: Janssen Korea, Ltd., Korea

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

1121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
001
bortezomib Injection into a vein 1.3 mg/m2 twice a week for 21 days
Drug: bortezomib
Injection into a vein 1.3 mg/m2 twice a week for 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
every cycles or every 3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
every cycle or every 3 weeks and end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Korea, Ltd., Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

October 29, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (Estimate)

November 1, 2009

Study Record Updates

Last Update Posted (Estimate)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 18, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR012958
  • bortezomib PMS (Other Identifier: Janssen Korea, Ltd., Korea)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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