A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT00431340
Recruitment Status :
(Terminated due to dose limiting toxicity)
This open-label study will assess anti-tumor activity and safety of belinostat in combination with bortezomib (Velcade®) in multiple myeloma patients refractory to or relapsed from at least one prior bortezomib-containing regimen. Subjects will be administered both PXD101 and bortezomib on the same days: i.e. days 1, 4, 8, and 11 of a 3-week cycle, for up to 8 cycles.
Objective response rate of belinostat administered in combination with bortezomib in multiple myeloma subjects who are refractory to or have relapsed from at least one prior bortezomib-containing regimen.
Safety of belinostat plus bortezomib.
Secondary Outcome Measures :
Duration of response, time to response (TTR), and time to progression (TTP).
Effect on biomarkers of bone metabolism. Effect on disease-related bone pain.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of multiple myeloma.
Status of refractory to or relapsed from at least one prior bortezomib-containing regimen.
Age >= 18 years.
Karnofsky performance status >= 60%
Acceptable liver function:
Bilirubin =< 1.5 x ULN (upper limit of normal)
Aspartate transaminase (AST) and alanine transaminase (ALT) =< 3 x ULN
Acceptable hematologic status:
Absolute Neutrophil Count (ANC) >= 1.5 x 109/L
Platelet count >= 100 x 109/L
Hemoglobin >= 9 g/dL
Coagulation status PT-INR/PTT =< 1.5 x ULN or in the therapeutic range if on anticoagulation therapy. (PT-INR/PTT= prothrombin - international normalized ratio / prothrombin time)
Serum potassium within normal range.
Estimated life expectancy greater than 3 months.
Signed, written IRB (institutional Review Board)-approved informed consent.
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.