Status:
COMPLETED
Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Bortezomib (Velcade) has just recently been approved by the FDA for the treatment of multiple myeloma in patients who have received at least two prior therapies and have demonstrated disease progressi...
Detailed Description
Primary Objective • To evaluate the objective response rate (CR + PR) to bortezomib alone in patients with newly diagnosed multiple myeloma. Secondary Objectives * To evaluate the tolerability and ...
Eligibility Criteria
Inclusion
- Diagnosis of multiple myeloma based upon standard criteria
- Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of \> 1 g/dl and/or urine monoclonal immunoglobulin spike of \> 200mg/24 hours.
- Karnofsky performance status of \> 60
- Hemoglobin \> 8.0 g/dL
- AST (SGOT) \< 3 x ULN
- ALT \< 3 x ULN
- Total bilirubin \< 2 x ULN
- Is infertile or is practicing an adequate form of contraception
- 18 years of age or older
Exclusion
- Prior treatment with systemic chemotherapy
- Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes
- Plasma cell leukemia
- Calculated or measured creatinine clearance \< 30 mL/minute within 14 days of enrollment
- Grade 2 or greater peripheral neuropathy
- Hypersensitivity to bortezomib, boron or mannitol
- Severe hypercalcemia
- HIV positive
- Known active hepatitis B or C
- New York Hospital Association Class III or IV heart failure
- Second malignancy requiring concurrent treatment
- Other serious medical or psychiatric illness
- Pregnant women
- Dialysis dependent patients
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00153920
Start Date
December 1 2003
End Date
September 1 2008
Last Update
June 11 2019
Active Locations (6)
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1
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30322
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115