Preemptive Strike With Bortezomib (VELCADE) in Participants With Multiple Myeloma Still Event-free on Total Therapy 2 (UARK 98-026)
18 Years
N/A
Both
Multiple Myeloma
Trial Information
Preemptive Strike With Bortezomib (VELCADE) in Participants With Multiple Myeloma Still Event-free on Total Therapy 2 (UARK 98-026)
Although advances in the treatment of multiple myeloma have led to improved remission rates,
the risk for serious relapse is very high. The drug Bortezomib has been highly effective for
treatment of the disease in an advanced stage such as post-transplant relapse. Due to the
need of maintenance therapies, it is necessary to look to certain drugs that may prolong
remission and increase the quality of life. Bortezomib, when taken at the beginning of
remission, may prove to be a beneficial maintenance drug for the management of multiple
myeloma.
Inclusion Criteria:
- Diagnosed with multiple myeloma currently or previously enrolled on UARK 98-026 and
currently event-free at the time of the evaluation.
- Performance status of 0-2 based of SWOG criteria
- Previously documented platelet count > 75,000/ul within a 35 days prior to enrollment
- Previously documented peripheral absolute neutrophil count >1,000/ul within 35 days
prior to enrollment.
- Adequate renal function
- Signed informed consent
- Female subject is post-menopausal or willing to use acceptable birth control
- Male subjects agree to use acceptable method of contraceptive
Exclusion Criteria:
- Hypersensitivity to Bortezomib, boron, or mannitol
- Female subject is pregnant or breastfeeding
- Experienced myocardial infraction within 6 months prior to enrollment
- Received other investigational new drugs within 14 days before enrollment
- Received any anti-myeloma therapy within 14 days
- Serious medical or psychiatric illness likely to interfere with participation in this
clinical study
- Diagnosed or treated for another malignancy within 3 years of enrollment
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Effect of Maintenance Therapy With Bortezomib on the Length of Remission in Participants Currently Receiving Maintenance Therapy as Part of Total Therapy 2
Outcome Description:
The number of patients on Bortezomib that have maintained event-free survival, compared to the patients on observation was not analyzed due to low attrition rates. Event-free survival is a measure of the proportion of people who remain free of a particular complication of disease (called an event) after treatment that is designed to prevent or delay that particular complication.
Outcome Time Frame:
three years
Safety Issue:
No
Principal Investigator
Bart Barlogie, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UAMS
Authority:
United States: Institutional Review Board
Study ID:
100241
NCT ID:
NCT00657553
Start Date:
February 2008
Completion Date:
January 2009
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy | Little Rock, Arkansas 72205 |
