This is a phase 2 study of perifosine in patients with multiple myeloma. Patients will receive perifosine 150 mg at bedtime (qhs) daily. Patients will be assessed by serum and/or urine-electrophoresis at least every 3 weeks.
Treatment: Patients will take three 50 mg tablets of perifosine qhs daily with food. All patients should continue therapy unless disease progression is documented on two occasions at least 1 week apart. Progressing patients will have dexamethasone 20 mg twice per week added to the perifosine. Patients who experience toxicity may continue on treatment with doses delayed or reduced. Evaluations: Serum and/or urine-electrophoresis will be evaluated for progression or response at 3 week intervals. This study will enroll a total of up to 64 patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
100 - 150 mg daily
20 mg twice weekly
Investigative Site
Berkeley, California, United States
Investigative Site
Duarte, California, United States
Investigative Site
Atlanta, Georgia, United States
Investigative Site
Chicago, Illinois, United States
Response rate (the combined CR + PR + MR) with treatment perifosine
To determine the response rate (the combined Complete Response (CR) + Partial Response (PR) + Minor Response (MR) following treatment with perifosine in patients with multiple myeloma who have relapsed following Initial front-line therapy and are refractory to their most recent therapy.
Time frame: Every 3 weeks
Response rate (CR + PR + MR) with combination therapy
To determine the response rate (CR + PR + MR) following treatment with combination therapy with perifosine plus dexamethasone in patients with multiple myeloma who have relapsed or were refractory to their most recent therapy before study enrollment, and failed to respond to or have relapsed following treatment with perifosine alone.
Time frame: Every 3 weeks
Assess the safety and tolerability of perifosine alone and in combination
To assess the safety and tolerability of perifosine alone and in combination with dexamethasone in patients with multiple myeloma.
Time frame: Every 3 weeks
Obtain correlative data in patients with multiple myeloma treated with perifosine and in combination
To obtain correlative data in patients with multiple myeloma treated with perifosine alone and in combination with dexamethasone.
Time frame: Every 3 weeks
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Investigative Site
Boston, Massachusetts, United States
Investigative Site
Ann Arbor, Michigan, United States
Investigative Site
Charlottesville, Virginia, United States