drugset / Trial / NCT01002248

Assessment of Efficacy and Safety of Perifosine, Bortezomib and Dexamethasone in Multiple Myeloma Patients

NCT01002248

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized Phase III study to evaluate the efficacy and safety of perifosine when added to the combination of bortezomib and dexamethasone in multiple myeloma patients who have relapsed on a prior bortezomib treatment regimen.

Timeline

Start
2009-12
Primary completion
2013-03
Completion
2013-03

Publications

  • Results Richardson PG, Nagler A, Ben-Yehuda D, Badros A, Hari P, Hajek R, Spicka I, Kaya H, Le Blanc R, Yoon SS, Kim K, Martinez-Lopez J, Mittelman M, Shpilberg O, Tothova E, Laubach JP, Ghobria IM, Leiba M, Gatt ME, Sportelli P, Chen M, Anderson KC. Randomized Placebo-Controlled Phase III Study Of Perifosine Combined With Bortezomib and Dexamethasone In Relapsed, Refractory Multiple Myeloma Patients Previously Treated With Bortezomib. Blood 2013 ASH Meeting Proceedings;122:abstract 3189

Drugs

EvaluationDrugModalityDoseRoute
Subject Perifosine Small molecule 50 mg Oral
Background Bortezomib Small molecule 1.3 mg/m2
Background Dexamethasone Small molecule 20 mg Oral

Indications