A Retreatment Study With Bortezomib for Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01030302
First received: October 29, 2009
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to monitor such factors as a past history, a previous history of drug use, the degree of response to initial treatment, the frequency of previous therapies, age, Eastern Cooperative Oncology Group (ECOG) performance status, which is used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis, before the bortezomib re-treatment, the concomitant drugs that are used for re-treatment and the pattern of treatment in patients with multiple myeloma who were re-treated with injectable bortezomib.


Condition Intervention Phase
Multiple Myeloma
Drug: bortezomib
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Observational, Prospective Analysis of Retreatment With Bortezomib for Multiple Myeloma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To monitor such factors as a past history, a previous history of drug use, the degree of responses to initial treatment, the frequency of previous therapies, age, the concomitant drugs that are used for re-treatment and the pattern of treatment. [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: at the end of every 3 week cycle ] [ Designated as safety issue: No ]
  • Overall response rate [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: November 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (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
bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days

Detailed Description:

It will be essential to obtain the Korean clinical data about the efficacy and safety of the re-treatment with bortezomib as well as to analyze its actual pattern. The current trial is a prospective, multi-center, Phase 4, observational study that will be conducted to collect such demographic data as a past history, a previous history of drug use, the degree of responses to initial treatment, the frequency of previous therapies, age, Eastern Cooperative Oncology Group (ECOG) performance status, the concomitant drugs that are used for re-treatment and the pattern of treatment for patients with multiple myeloma and who were re-treated with injectable bortezomib. Also safety data will be collected. 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

Among patients who are scheduled to be re-treated with bortezomib for the recurrence of multiple myeloma and who have submitted a written informed consent to provide their personal data in relation to their former, prescribed use of bortezomib for the treatment of multiple myeloma in Korea.

Criteria

Inclusion Criteria:

  • Patients with multiple myeloma
  • Patients who were treated with bortezomib monotherapy or bortezomib combination therapy
  • Patients who relapsed after >= six months interval since last dose of bortezomib
  • Patients who had a treatment response of higher than partial remission (PR) to the previous bortezomib therapy
  • Patients who were fully aware of the objectives and essential procedures of the current trial and then submitted a written informed consent declaring that they will voluntarily participate in the current trial

Exclusion Criteria:

  • The current presence of or a past history of hypersensitivity to bortezomib or its constituents
  • Severe hepatic dysfunction (AST or ALT at first use>= x 5 upper normal)
  • Pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030302

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

Additional Information:
No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01030302     History of Changes
Other Study ID Numbers: CR015814, 26866138MMY4039, BORKOR5021
Study First Received: October 29, 2009
Last Updated: March 7, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Bortezomib retreatment
Velcade
Proteasome inhibitor
Bortezomib

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
Proteasome Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014