A Retreatment Study With Bortezomib for Multiple Myeloma
An Observational, Prospective Analysis of Retreatment With Bortezomib for Multiple Myeloma
3 other identifiers
observational
56
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 29, 2009
CompletedFirst Posted
Study publicly available on registry
December 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedMarch 8, 2013
March 1, 2013
1.8 years
October 29, 2009
March 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6-12 months
Secondary Outcomes (2)
Adverse events
at the end of every 3 week cycle
Overall response rate
6-12 months
Study Arms (1)
001
bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Korea, Ltd. Clinical Trial
Janssen Korea, Ltd.
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
December 11, 2009
Study Start
November 1, 2008
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
March 8, 2013
Record last verified: 2013-03