A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma

Exclusion Criteria

• •Non-secretory multiple myeloma or symptomatic amyloidosis.
• •Hypersensitivity to bortezomib, boron, or mannitol.
• •Less than 4 weeks since prior chemotherapy, radiotherapy, endocrine therapy, or immunotherapy, except if disease is rapidly progressing.
• •Less than 4 weeks since prior use of other investigational agents.
• •Serious concomitant systemic disorders (e.g. active infection).
• •Significant cardiovascular disease.
• •Marked baseline prolongation of QT/QTc (corrected QT interval)interval.
• •Central nervous system disorders requiring neuroleptics / anti-convulsants.
• •Peripheral sensory neuropathy of ≥ Grade 2
• •Renal insufficiency defined as a creatinine clearance of \< 30 ml/min.
• •Non-willingness to use effective contraceptive methods for patients of child-bearing age / potential.
• •Pregnant or breast-feeding women.
• •Known HIV positivity.
• •Prior treatment with belinostat (PXD101), or any other HDAC (histone deacetylase) inhibitor.
• •Altered mental status which precludes an understanding of the Informed Consent Document.