Bortezomib and Bendamustine to Treat Relapsed/Refractory Myeloma

Inclusion Criteria

• •1. Voluntary written informed consent
• •2. Age 18 years or older
• •3. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
• •4. Male subject agrees to use an acceptable method for contraception for the duration of the study.
• •5. Diagnosis of multiple myeloma based on standard criteria as follows:
• •Major Criteria
• •* Plasmacytomas on tissue biopsy
• •* Bone marrow plasmacytosis (\>30% plasma cells)
• •* Monoclonal immunoglobulin spike on serum electrophoresis (IgG \>3.5 g/dL or IgA \>2.0 g/dL) or kappa or lambda light chain excretion \>1 g/day on 24 hour urine protein electrophoresis
• •Minor Criteria
• •* Bone marrow plasmacytosis (10 to 30% plasma cells)
• •* Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
• •* Lytic bone lesions
• •* Normal IgM \<50 mg/dL, IgA \<100 mg/dL, or IgG \<600 mg/dL
• •* Any of the following sets of criteria will confirm the diagnosis of Multiple Myeloma:
• •* Any two of the major criteria or
• •* 1 major plus 2 minor criteria.
• •6. Measurable disease, defined as a monoclonal immunoglobulin spike (M-Spike) on serum electrophoresis of ≥1 g/dL and/or urine monoclonal immunoglobulin spike of ≥200 mg/24 hours. Non-secretors must have measurable protein by Freelite or measurable disease by plasmacytoma to be eligible.
• •7. Patients must have refractory myeloma as defined by a greater than 25% increase in their M-protein. They should have progressed on bortezomib.
• •8. Karnofsky performance status ≥50
• •9. Patients treated with local radiotherapy with or without a brief exposure to steroids are eligible. Patients who require radiotherapy should have entry to the protocol deferred until the radiotherapy is completed by at least 4 weeks prior to initiation of study drug.
• •10. Meets the following pretreatment laboratory criteria at baseline (Day 1 of Cycle 1, before study drug administration)
• •* Absolute neutrophil count ≥1 x 10\^3/uL
• •* Platelet count ≥75 x 10\^3/uL
• •* Hemoglobin ≥8.0 g/dL
• •* Calculated or measured CrCL ≥ 40 mL/min
• •* AST or ALT and total bilirubin \< 3 x ULN
• •11. Echocardiogram with a \>50% Ejection Fraction