Status:
TERMINATED
Preemptive Strike With Bortezomib in Multiple Myeloma Patients
Lead Sponsor:
University of Arkansas
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate whether using the drug bortezomib at the start of remission will prevent relapse for a longer period of time.
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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 Southwest Oncology Group (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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00657553
Start Date
February 1 2008
End Date
January 1 2009
Last Update
November 20 2017
Active Locations (1)
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1
University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy
Little Rock, Arkansas, United States, 72205