Multiple Myeloma
Conditions
Keywords
Multiple myeloma, myeloma, plasma cell myeloma, bone marrow cancer, myelomatosis, Kahler's disease, PXD101, belinostat, bortezomib
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 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.
Interventions
DRUGPXD101
Sponsors
Valerio Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Duration of response, time to response (TTR), and time to progression (TTP). | — |
| Effect on biomarkers of bone metabolism. Effect on disease-related bone pain. | — |
Countries
United States
Outcome results
None listed