Vorinostat and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma

Completed · Phase 1

Conditions studied: Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

In brief

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 bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with bortezomib may kill more cancer cells

Key facts

Study ID

NCT00310024

Run by

National Cancer Institute (NCI)

People needed

40

Starts

2005-11-01

Last updated by the study team

2013-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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