A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00431340
• Other study ID #: PXD101-CLN-16
• Status: Terminated
• Phase: Phase 2
• First received: February 2, 2007
• Last updated: July 7, 2015
• Start date: March 2007
• Est. completion date: June 2007

Study information

• Verified date: July 2015
• Source: Onxeo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• PXD101

Locations

Country	Name	City	State
United States	Center for cancer and blood disorders	Bethesda	Maryland
United States	Baylor University Medical Center	Dallas	Texas
United States	Oncotherapeutics	West Hollywood	California

Sponsors (1)

Lead Sponsor	Collaborator
Onxeo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Safety of belinostat plus bortezomib.
Secondary	Duration of response, time to response (TTR), and time to progression (TTP).
Secondary	Effect on biomarkers of bone metabolism. Effect on disease-related bone pain.