Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma

Inclusion Criteria:

The patient:

* has a diagnosis of multiple myeloma.
* currently has multiple myeloma with measurable disease.
* must have received at least 1 previous treatment regimen and shows signs of progressive disease at the time of study entry.
* if a woman of child bearing potential (not surgically sterile or at least 12 months naturally postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
* if a man, must agree to use an acceptable method of contraception throughout the study and for 90 days after last dose study drug.
* must have an Eastern Cooperative Oncology Group (ECOG) performance status not greater than 2.
* must have a life-expectancy of greater than 3 months.
* must meet specific protocol-related hematological and laboratory criteria within 14 days of enrollment.

Exclusion Criteria:

The patient has:

* had a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix).
* plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes (POEMS) syndrome.
* plasma cell leukemia.
* non-measurable multiple myeloma.
* Common Terminology Criteria for Adverse Events (CTCAE) grade 2 (or greater) peripheral neuropathy within 14 days before enrollment.
* previously participated in a Cephalon-sponsored clinical study with bendamustine.
* impaired cardiac function or clinically significant cardiac diseases.
* undergone major surgery within 4 weeks prior to screening or has not recovered from side effects of such therapy.
* severe hypercalcemia.
* other concurrent severe and/or uncontrolled medical or psychiatric conditions.
* known positivity for human immunodeficiency virus (HIV) or hepatitis B or C.
* a history of allergic reaction attributable to compounds of similar chemical or biological composition to bendamustine, bortezomib, boron, or mannitol.
* received chemotherapy within 3 weeks before enrollment, with the exception of nitrosoureas, which should be discontinued at least 6 weeks before enrollment.
* received corticosteroids (greater than 10 mg/day prednisone or equivalent) within 3 weeks before enrollment.
* received immunotherapy, antibody, or radiation therapy within 4 weeks before enrollment.
* a status as a pregnant or lactating woman. Any women becoming pregnant during the study will be withdrawn from the study.
* a status as a male whose sexual partner is a woman of childbearing potential not using effective birth control.
* used an investigational drug within 1 month before the screening visit.