Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring multiple myeloma, Velcade, bortezomib
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Emory Winship Cancer Institute
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- Roswell Park Cancer Institute
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Experimental
bortezomib
Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.