drugset / Trial / NCT00415064

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

NCT00415064

Phase 1 Completed 32 enrolled AEterna Zentaris
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2006-12
Primary completion
2012-07
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified 15 mg
Subject Lenalidomide Other / unclassified 25 mg
Subject Perifosine Small molecule 50 mg
Subject Perifosine Small molecule 100 mg
Background Dexamethasone Small molecule 20 mg

Indications