NCT00375791

Efficacy of Perifosine Alone and in Combination With Dexamethasone for Patients With Multiple Myeloma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: AEterna Zentaris · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	perifosine	100 - 150 mg daily
DRUG	dexamethasone	20 mg twice weekly

Timeline

• Start date: 2005-12-01
• Primary completion: 2010-12-01
• Completion: 2011-10-01
• First posted: 2006-09-13
• Last updated: 2018-02-28

Locations

7 sites across 1 country: United States