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

This study has been terminated.
(Terminated due to dose limiting toxicity)
Information provided by (Responsible Party):
Onxeo Identifier:
First received: February 2, 2007
Last updated: July 7, 2015
Last verified: July 2015
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.

Condition Intervention Phase
Multiple Myeloma
Drug: PXD101
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma

Resource links provided by NLM:

Further study details as provided by Onxeo:

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.

Enrollment: 4
Study Start Date: March 2007
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
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Please refer to this study by its identifier: NCT00431340

United States, California
West Hollywood, California, United States, 90069
United States, Maryland
Center for cancer and blood disorders
Bethesda, Maryland, United States, 20817
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
  More Information

Responsible Party: Onxeo Identifier: NCT00431340     History of Changes
Other Study ID Numbers: PXD101-CLN-16
Study First Received: February 2, 2007
Last Updated: July 7, 2015

Keywords provided by Onxeo:
Multiple myeloma
plasma cell myeloma
bone marrow cancer
Kahler's disease

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017