Efficacy of Perifosine Alone and in Combination With Dexamethasone for Patients With Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00375791|
Recruitment Status : Completed
First Posted : September 13, 2006
Last Update Posted : February 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: perifosine Drug: dexamethasone||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||October 2011|
U.S. FDA Resources
Experimental: Perifosine daily
Patients will take three 50 mg tablets of perifosine daily at bedtime with food. Patients will be examined every three weeks. If patients have no progression it is allowed to receive 8 cycles of perifosine
100 - 150 mg daily
Experimental: Perifosine daily + Dexa twice per week
Patients will take three 50 mg tablets of perifosine daily at bedtime with food until progression. If progressive disease is confirmed by a second measurement at least one week later the patient will receive a combination of 20 mg twice per week dexamethasone (dexa) and 150 mg perifosine daily at bedtime.
100 - 150 mg daily
Other Names:Drug: dexamethasone
20 mg twice weekly
Other Name: decadron
- Response rate (the combined CR + PR + MR) with treatment perifosine [ Time Frame: Every 3 weeks ]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.
- Response rate (CR + PR + MR) with combination therapy [ Time Frame: Every 3 weeks ]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.
- Assess the safety and tolerability of perifosine alone and in combination [ Time Frame: Every 3 weeks ]To assess the safety and tolerability of perifosine alone and in combination with dexamethasone in patients with multiple myeloma.
- Obtain correlative data in patients with multiple myeloma treated with perifosine and in combination [ Time Frame: Every 3 weeks ]To obtain correlative data in patients with multiple myeloma treated with perifosine alone and in combination with dexamethasone.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375791
|United States, California|
|Berkeley, California, United States, 94704|
|Duarte, California, United States, 91010|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|Ann Arbor, Michigan, United States, 48103|
|United States, Virginia|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Paul Richardson, M.D||Dana-Farber Cancer Institute|