NCT00415064

Phase I Study of Perifosine + Lenalidomide and Dexamethasone for Patients With Multiple Myeloma

An Open-Label Phase I Study of the Safety of Perifosine in Combination With Lenalidomide and Dexamethasone for Patients With Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: AEterna Zentaris · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I study of perifosine in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma. The current protocol will enroll patients with relapsed or refractory multiple myeloma requiring second or third line therapy. Six patients each will be treated with at one of 4 dose levels in a phase 1 study. All patients will receive perifosine, lenalidomide and dexamethasone of each 28 day cycle. The doses of perifosine and lenalidomide will be varied in each group. The dose of dexamethasone will remain constant.

Detailed description

This is a phase I study of perifosine in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma. All patients will receive lenalidomide daily for days 1 to 21 of each 28 day cycle. Perifosine will be given daily qhs with food. Dexamethasone will be given on days 1-4, 9-12 and 17-20 for 4 cycles. After 4 cycles dexamethasone will be given only on days 1-4. Four dose levels will be studied: 1. Perifosine 50 mg, lenalidomide 15 mg and dexamethasone 20 mg 2. Perifosine 50 mg, lenalidomide 25 mg and dexamethasone 20 mg 3. Perifosine 100 mg, lenalidomide 15 mg and dexamethasone 20 mg 4. Perifosine 100 mg, lenalidomide 25 mg and dexamethasone 20 mg Six patients will be enrolled at each dose level until the maximum tolerated dose (MTD) is reached. Six additional patients will be treated at the MTD.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Perifosine	Perifosine given in either 50 mg or 100 mg / day
DRUG	Lenalidomide	Lenalidomide given in either 15 or 25 mg / day
DRUG	Dexamethasone	Dexamethasone given in 20 mg / day

Timeline

• Start date: 2006-12-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2006-12-22
• Last updated: 2012-07-06

Locations

1 site across 1 country: United States