Clinical Trial Details for Study "GCC 0960"

Official Title: 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 Previously Treated with Bortezomib
Investigator: Ashraf Badros, M.D.
Summary: This is a randomized, double-blind, placebo controlled, two-arm 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. The study will consist of two phases; Core Phase and Extension Phase. Patients who complete the Core Phase will be permitted to enter the Extension Phase.
Disease site: Multiple Myeloma
Disease stage: Relapsed/Refractory
Condition: Previously Treated
Intervention: Perifosine Added to the Combination of Bortezomib and Dexamethasone
Phase: III
Study number: GCC 0960
Eligibility*
(inclusion criteria)
    Bortezomib Relapsed-Documented progression > 60 days after the last dose of bortezomib based treatment; Patients with a confirmed diagnosis of relapsed or relapsed/refractory multiple myeloma that are currently progressing or have recently relapsed; Measurable disease as defined by the protocol: Patients must have relapsed (progressed > 60 days) after their last dose of bortezomib based therapy; Patients must have previously received at least two cycles of either single agent bortezomib treatment (21 day cycle) as per the protocol; Patient must be willing and able to participate in PK sampling.
(exclusion criteria)
    Patients refractory to any regimen containing bortezomib; Patients with non-secretory multiple myeloma. (myeloma where the malignant plasma cells do not secrete M protein or light chains); 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.
Contact Person
 Kathleen Tiefenwerth, RN 410-328-6635
Sunita Philip, MS 410-328-8199
Pat Lesho, RN 410-328-2577
* Note: This study may include eligibility criteria that are not listed here. For more information about the study or to find out if you are eligible, call 1-800-888-8823.


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