Multiple Myeloma Clinical Trial
Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma
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 progression on the last therapy. This study will determine if Velcade is effective in treating patients with multiple myeloma that have had no prior treatment for the disease. We will also use whole-genome scanning to identify drug response biomarkers in bone marrow samples as well as nerve fiber studies to compare nerves prior to the use of Velcade and after treatment with Velcade.
Full 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 toxicity.
To evaluate time to progression.
To assess the frequency and severity of peripheral neuropathy.
To evaluate the impact of early intervention with dose modification and explore symptomatic treatment of peripheral neuropathy.
Exploratory Objectives
• To perform pharmacogenomic analysis of molecular markers associated with response or non-response.
Statistical Design A one stage design is used to evaluate ORR. With 60 evaluable participants, if at least 27 objective responses are observed then bortezomib will be considered promising. The probability of concluding the treatment promising is >0.95 with a true ORR of 55% and <0.07 with a true ORR of 35%.
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
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There are 5 Locations for this study
Atlanta Georgia, 30322, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02115, United States
Buffalo New York, 04263, United States
New York New York, 10021, United States
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