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

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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.

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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Winnipeg,
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Christiansburg, VA
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Colorado Springs, Colorado 80910
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