MedTrace Logo

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

NCT01005628 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1121

Last updated 2013-02-20

No results posted yet for this study

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).

Conditions

Interventions

DRUG

bortezomib

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

Sponsors & Collaborators

  • Janssen Korea, Ltd., Korea

    lead INDUSTRY

Principal Investigators

  • Janssen Korea, Ltd. Clinical Trial · Janssen Korea, Ltd.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01005628 on ClinicalTrials.gov