Study Combining Bortezomib With High Dose Melphalan to Treat Multiple Myeloma

Inclusion Criteria

• A confirmed diagnosis of multiple myeloma
• Show progression of disease after a previous cycle of dose-intense melphalan, or less than 25% decrease in paraprotein measured at 8 weeks after a prior cycle of dose-intense melphalan
• May have received intervening therapies for disease progression after dose-intense melphalan and enrollment in this protocol
• Age:18yrs-76yrs at time of melphalan administration
• Gender: There is no gender restriction
• Availability of >2x10^6 autologous peripheral blood CD34+ cells/kg or a syngeneic donor meeting eligibility criteria for syngeneic donation
• Syngeneic transplantation is preferred
• For patients enrolled in the phase I part of this study, >1x10^6 autologous or syngeneic peripheral blood CD34+ cells/kg remaining in storage as "backup" in case of engraftment failure
• Recovery from complications of salvage therapy, if administered -

Exclusion Criteria

• Diagnosis other than multiple myeloma
• Chemotherapy or radiotherapy within 28 days of initiating treatment in this study
• Prior dose-intense therapy within 56 days of initiating treatment in this study
• Uncontrolled bacterial,viral,fungal or parasitic infections
• Uncontrolled CNS metastases
• Known amyloid deposition in heart
• Organ dysfunction
• LVEF 2x or AST>3x ULN
• Measured creatinine clearance <20ml/min
• Sensory peripheral neuropathy grade 4
• Karnofsky score<70% unless a result of bone disease directly caused by myeloma
• Life expectancy limited by another co-morbid illness
• History of another malignancy in remission <2yrs (other than basal cell carcinoma)
• Pregnant (women)or unwilling to use acceptable birth control methods (men or women) for twelve months after treatment
• Documented hypersensitivity to melphalan or bortezomib or any components of the formulation
• Patients unable or unwilling to provide consent