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

An Open-Label Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma

The primary objective of this study is to assess the safety and tolerability of bendamustine as combination therapy with bortezomib for patients with relapsed/refractory multiple myeloma (MM).

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.