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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01005628
First received: October 29, 2009
Last updated: February 18, 2013
Last verified: February 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Multiple Myeloma
 Drug: bortezomib
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Velcade - Regulatory Post Marketing Surveillance (PMS)

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib
U.S. FDA Resources

Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 1121
Study Start Date: June 2006
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005628

Locations
Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
  More Information

No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01005628     History of Changes
Other Study ID Numbers: CR012958, bortezomib PMS
Study First Received: October 29, 2009
Last Updated: February 18, 2013
Health Authority: Korea: Food and Drug Administration
Republic of Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Bortezomib postmarketing surveillance
Korea bortezomib PMS

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
 Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013