Safety and Efficacy Study of Single Weekly Bortezomib in Newly Diagnosed Multiple Myeloma

Inclusion Criteria

• •1. Diagnosis of multiple myeloma based on standard criteria.
• •2. Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of \> 1Gm/dL and/or urine monoclonal immunoglobulin spike of \> 200mg/24 hours.
• •3. Non-secretors must have measurable protein by Freelite or measurable disease such as plasmacytoma to be eligible.
• •4. Patient must not have been previously treated with chemotherapy. Prior treatment of hypercalcemia with corticosteroids, or bisphosphonates does not disqualify the patient.
• •5. Patient must be ineligible for autologous stem cell transplant due to one or more of the following reasons:
• •* Age\>65
• •* Impaired renal function (creatinine≥2.0 mg/dL)
• •* Impaired pulmonary function (DLCO≤50%)
• •* Poor performance status (KPS≤80)
• •* Other prohibitive comorbid disorder
• •* 5b. Patients≥60 who decline autologous stem cell transplant are eligible for this study.
• •* 5c. Patients who are eligible but wish to postpone autologous stem cell transplant are eligible for this study.
• •6. Karnofsky performance status\>50
• •7. Patients treated with local radiotherapy with or without a brief exposure to steroids are eligible. Patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed, followed by a four week wash out period Spot RT to ≤3 vertebrae acceptable prior to entry.
• •8. Meets the following pretreatment laboratory criteria at Baseline (Within 14 days prior to study drug administration):
• •1. Platelet count\>50x10\^9/L or, if the bone marrow is extensively infiltrated,\>30x10\^9/L
• •2. Hemoglobin\>8.0G/dL
• •3. Absolute neutrophil count \>1.0x10\^9/L or, if the bone marrow is extensively infiltrated, \>0.5x10\^9/L
• •9. Meets the following pretreatment laboratory criteria for liver function tests at the screening visit conducted within 14 days of registration
• •1. AST (SGOT): \<3 times the upper limit of institutional laboratory normal
• •2. ALT (SGPT): \<3 times the upper limit of institutional laboratory normal
• •3. Total bilirubin: \<2 times the upper limit of institutional laboratory normal, unless clearly related to the disease
• •10. Women with child-bearing potential should be practicing an adequate form of contraception, as judged by the investigator (i.e. birth control pills, double barrier method, abstinence, etc.) or be surgically sterile or 12 months post-menopausal. Male subject agrees to use an acceptable method for contraception for the duration of the study.
• •11. Age 18 years or older
• •12. Has given voluntary written informed consent.