Preemptive Strike With Bortezomib in Multiple Myeloma Patients

• Status: Terminated
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate whether using the drug bortezomib at the start of remission will prevent relapse for a longer period of time.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas
• Treatments: Bortezomib

Criteria

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 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 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