An Open-Label Phase II Study of the Safety and Efficacy of Perifosine Alone and in Combination With Dexamethasone for Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (the combined complete response [CR] + partial response [PR] + minor response [MR]) following treatment with perifosine
Every 3 weeks
Paul Richardson, M.D
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Investigative Site||Beverly Hills, California|
|Investigative Site||Hinsdale, Illinois|
|Investigative Site||Grand Rapids, Michigan|
|Investigative Site||Atlanta, Georgia 30322|
|Investigative Site||Boston, Massachusetts 02115|
|Investigative Site||Charlottesville, Virginia 22908|