Study to Evaluate the Combination of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients With Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy

Inclusion Criteria

• Patients must meet the Durie and Salmon criteria for initial diagnosis of multiple myeloma.
• Previously histologically confirmed, multiple myeloma with indication for therapy including one of the following:
• Hemoglobin 11.5 mg/dl
• Creatinine >2 mg/dl
• Lytic bone lesions or severe osteopenia
• Extramedullary plasmacytomas
• Patients should not be considered candidates for high dose therapy/autologous stem cell transplantation due to coexistent medical conditions, advanced age, poor performance status, refusal of high dose chemotherapy, or other reasons as judged by the patient and/or physician.
• ECOG Performance Status 0-2.
• WBC ≥3000/mL; ANC ≥1000/mL; platelets ≥50, 000/mL (patients with platelets ≥30,000/mL are eligible if thrombocytopenia is felt to be due to extensive bone marrow involvement with myeloma).
• Patients with adequate organ function as measured by:

Renal: Serum creatinine 30 mL/minute.

Hepatic: Total bilirubin 180 or diastolic BP >100mm Hg)or uncontrolled cardiac arrhythmias.

• Prior to study entry, any ECG abnormality at Screening must be documented by the investigator as not medically relevant.
• Other serious medical conditions or psychiatric illness that would potentially interfere with patient participation in this trial.
• A second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix,unless the tumor was treated with curative intent at least 2 years previously or low-risk prostate cancer after curative therapy.
• Known hypersensitivity to bortezomib, boron, or mannitol.
• Female patient is pregnant or lactating. Confirmation that female patients of childbearing potential are not pregnant must be established by a negative serum pregnancy test ≤7 days prior to start of treatment.