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

NCT01005628 | Completed

• 2 other identifiers: CR012958bortezomib PMS
• Study Type: observational
• Target: 1,121
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Myeloma

Keywords

Bortezomib postmarketing surveillance; Korea bortezomib PMS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

001

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

Drug: bortezomib

Interventions

bortezomib DRUG

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

001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen Korea, Ltd. Clinical Trial

  Janssen Korea, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: November 2, 2009
• Study Start: June 1, 2006
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

KR (1)