A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
| Status: | Terminated |
|---|---|
| Conditions: | Blood Cancer, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2007 |
| End Date: | June 2007 |
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.
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.
Inclusion Criteria:
- 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 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.
We found this trial at
3
sites
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
Click here to add this to my saved trials
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
Click here to add this to my saved trials
Click here to add this to my saved trials