Back to resultsA Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PXD101
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple myeloma, myeloma, plasma cell myeloma, bone marrow cancer, myelomatosis, Kahler's disease, PXD101, belinostat, bortezomib
Eligibility Criteria
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.
Sites / Locations
- Oncotherapeutics
- Center for cancer and blood disorders
- Baylor University Medical Center
Outcomes
Primary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00431340
Brief Title
A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
Official Title
A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to dose limiting toxicity
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Onxeo
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple myeloma, myeloma, plasma cell myeloma, bone marrow cancer, myelomatosis, Kahler's disease, PXD101, belinostat, bortezomib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
PXD101
Primary Outcome Measure Information:
Title
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.
Title
Safety of belinostat plus bortezomib.
Secondary Outcome Measure Information:
Title
Duration of response, time to response (TTR), and time to progression (TTP).
Title
Effect on biomarkers of bone metabolism. Effect on disease-related bone pain.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Oncotherapeutics
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Center for cancer and blood disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
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