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

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

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

Inclusion Criteria:

- Diagnosis of multiple myeloma.

- Status of refractory to or relapsed from at least one prior bortezomib-containing

- 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)

- Altered mental status which precludes an understanding of the Informed Consent

Type of Study:


Study Design:

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

Outcome 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.

Principal Investigator

James Berenson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James R. Berenson, MD, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

June 2007

Related Keywords:

  • Multiple Myeloma
  • Multiple myeloma
  • myeloma
  • plasma cell myeloma
  • bone marrow cancer
  • myelomatosis
  • Kahler's disease
  • PXD101
  • belinostat
  • bortezomib
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Baylor University Medical CenterDallas, Texas  75246
Center for Cancer and Blood DisordersBethesda, Maryland  20817
OncotherapeuticsLos Angeles, California  90067