Safety & Efficacy Study of Perifosine + Bortezomib +/- Dexamethasone for Multiple Myeloma Patients

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

August 31, 2006

Primary Completion Date

December 31, 2010

Study Completion Date

July 31, 2011

Conditions
Multiple MyelomaMultiple Myeloma in Relapse
Interventions
DRUG

Perifosine

"Phase I: Patients will receive daily perifosine (doses 50 mg/m2 or 100 mg/m2) at bedtime.~Phase II: All patients will receive daily perifosine at bedtime. Patients will be evaluated every 3 weeks."

DRUG

Bortezomib

Phase I: Patients will receive 1 mg/m2 or 1.3 mg/m2 on days 1, 4, 8, and 11 every 3 weeks. Phase II: Patients will receive bortezomib on days 1,4,8 and 11 every 3 weeks.

DRUG

Dexamethasone

Phase II: If the patient shows progressive disease after 3 weeks, dexamethasone 20 mg will be added to perifosine and bortezomib on days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 18, and 19 to perifosine at bedtime and bortezomib IV on days 1, 4, 8, and 11 q 21 days.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AEterna Zentaris

INDUSTRY