Status:
COMPLETED
Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase I study will evaluate the feasibility and toxicity of weekly bortezomib in the treatment of relapsed or refractory multiple Myeloma and determine whether a twice-weekly schedule of bortezom...
Detailed Description
Upon determination of eligibility, patients will be receive: * Bortezomib
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Multiple Myeloma
- Received no more than 2 previous treatment regimens for multiple Myeloma
- ECOG performance status 0, 1, or 2
- Serum creatinine \< 2.0mg/dL
- calculated or measured creatinine clearance \> 30ml/minute
- Measurable or evaluable disease
- Provide written informed consent prior to receiving protocol therapy.
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Moderate or severe peripheral neuropathy
- Other serious medical conditions
- Other active malignancies
- history of treatment for other invasive cancers
- Women who are pregnant or lactating
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00193557
Start Date
May 1 2004
End Date
January 1 2009
Last Update
June 29 2010
Active Locations (2)
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1
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
2
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023