Study to Assess the Efficacy and Safety of Perifosine Added to the Combination of Bortezomib and Dexamethasone in Multiple Myeloma Patients
Phase: Phase 3
Diagnosis: Multiple Myeloma
NCT ID: NCT01002248
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 09-401
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.
Dana-Farber Cancer Institute, Brigham and Women's Hospital
Paul Richardson, MD,
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute:
Kathleen Colson, 617-632-6303,
- Patient was previously diagnosed with multiple myeloma based on standard diagnostic
- 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.
- 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.