NCT01002248

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

A Phase III Randomized Study to Assess the Efficacy and Safety of Perifosine Added to the Combination of Bortezomib and Dexamethasone in Multiple Myeloma Patients

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: AEterna Zentaris · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A pre-planned interim analysis is expected to take place in Q1 of 2013.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Perifosine	Perifosine will be dosed as one 50 mg pill every day of each cycle.
DRUG	Perifosine Placebo	Perifosine placebo will be dosed as one 50 mg pill every day of each cycle.
DRUG	Bortezomib	Bortezomib will be dosed at 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days.
DRUG	Dexamethasone	Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2009-10-27
• Last updated: 2018-02-09

Locations

86 sites across 9 countries: United States, Canada, Czechia, Ireland, Israel, Russia, Slovakia, South Korea, Spain