Status:
TERMINATED
Assessment of Efficacy and Safety of Perifosine, Bortezomib and Dexamethasone in Multiple Myeloma Patients
Lead Sponsor:
AEterna Zentaris
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
A pre-planned interim analysis is expected to take place in Q1 of 2013.
Eligibility Criteria
Inclusion
- Patient was previously diagnosed with multiple myeloma based on standard diagnostic criteria.
- Patients must have relapsed (progressed \> 60 days) after their last dose of bortezomib-based therapy. In addition, patients may be relapsed or refractory to other non-bortezomib-based therapies.
- Patient has received at least 1 but not more than 4 prior anti-myeloma regimens and has progressive disease after the most recent treatment regimen.
- Patients must have adequate organ and marrow function.
Exclusion
- Patients must not be refractory to any bortezomib-containing regimen.
- History of allergic reactions or intolerance attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine), bortezomib or dexamethasone or any of their components.
- Prior treatment with perifosine or an investigational proteasome inhibitor.
- Chemotherapy or other therapy experimental or proven that is or may be active against myeloma within two weeks (14 days) prior to Cycle 1 Day 1.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT01002248
Start Date
December 1 2009
End Date
March 1 2013
Last Update
February 9 2018
Active Locations (86)
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1
La Verne, California, United States, 91750
2
San Francisco, California, United States, 94143
3
San Pablo, California, United States, 94806
4
Aurora, Colorado, United States, 80012