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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Bortezomib; Vorinostat

Criteria

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