Clinical trial · Interventional
A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
NCT00431340CI-TRIAL-00018486terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to dose limiting toxicity
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PXD101 | Drug | Belinostat | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- 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.
- measure
- Safety of belinostat plus bortezomib.
Secondary outcomes (2)
- measure
- Duration of response, time to response (TTR), and time to progression (TTP).
- measure
- Effect on biomarkers of bone metabolism. Effect on disease-related bone pain.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.