Assessment of Efficacy and Safety of Perifosine, Bortezomib and Dexamethasone in Multiple Myeloma Patients
Status: | Terminated |
---|---|
Conditions: | Blood Cancer, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/11/2018 |
Start Date: | December 2009 |
End Date: | March 2013 |
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
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.
added to the combination of bortezomib and dexamethasone in multiple myeloma patients who
have relapsed on a prior bortezomib treatment regimen.
A pre-planned interim analysis is expected to take place in Q1 of 2013.
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
39
sites
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