Status:
COMPLETED
Vorinostat and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Refractory Multiple Myeloma
Stage I Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of vorinostat when given together with bortezomib in treating patients with relapsed or refractory multiple myeloma. Vorinostat and bortez...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of vorinostat (SAHA) when given together with bortezomib in patients with relapsed or refractory multiple myeloma (MM). II. Determin...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically and clinically confirmed multiple myeloma
- Relapsed or refractory disease after prior chemotherapy or transplantation\*
- Measurable disease, defined by quantitative immunoglobulin levels in serum and/or urine and bone marrow plasmacytosis
- Non-secretory disease allowed provided MRI or positron emission tomography or CT scan can accurately measure at least one plasmacytoma lesion
- No known CNS involvement
- Life expectancy \> 3 months
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Absolute neutrophil count ≥ 1,000/mm³ (unless myelosuppression is secondary to bone marrow plasmacytosis \[\> 80% involvement\])
- Platelet count ≥ 50,000/mm³ (unless myelosuppression is secondary to bone marrow plasmacytosis \[\> 80% involvement\])
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- AST and ALT ≤ 2 times ULN
- Creatinine \< 2 mg/dL OR creatinine clearance \> 40 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to swallow pills
- Patients with a history of seizures are eligible provided seizures are under adequate control with non-enzyme inducing anticonvulsant medication
- No history of allergic reactions attributed to study agents
- No sensory or motor neuropathy ≥ grade II
- No uncontrolled current illness including, but not limited to, the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would limit study compliance
- No grade 3 QT prolongation (i.e., \> 500 msec) at baseline
- See Disease Characteristics
- Prior bortezomib allowed
- At least 2 weeks since prior therapy for multiple myeloma
- Concurrent growth factors (filgrastim \[G-CSF\] and epoetin alfa) to sustain peripheral blood counts (during the first course of therapy only) allowed
- Concurrent steroid therapy (≤ 20 mg of prednisone) for patients requiring chronic use for disorders other than myeloma allowed
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational or commercial agents or therapies for this malignancy
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00310024
Start Date
November 1 2005
Last Update
February 7 2013
Active Locations (1)
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1
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201-1595