Status:
TERMINATED
A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
Lead Sponsor:
Valerio Therapeutics
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Diagnosis of multiple myeloma.
- Status of refractory to or relapsed from at least one prior bortezomib-containing regimen.
- Progressive disease.
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00431340
Start Date
March 1 2007
End Date
June 1 2007
Last Update
July 8 2015
Active Locations (3)
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1
Oncotherapeutics
West Hollywood, California, United States, 90069
2
Center for cancer and blood disorders
Bethesda, Maryland, United States, 20817
3
Baylor University Medical Center
Dallas, Texas, United States, 75246