Assessment of Efficacy and Safety of Perifosine, Bortezomib and Dexamethasone in Multiple Myeloma Patients

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT01002248

Run by

AEterna Zentaris

People needed

135

Starts

2009-12-01

Expected to finish

2013-03-01

Last updated by the study team

2018-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — San Francisco, California, United States
• Study site — San Pablo, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Boulder, Colorado, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Lakewood, Colorado, United States
• Study site — Littleton, Colorado, United States
• Study site — Longmont, Colorado, United States
• Study site — Parker, Colorado, United States
• Study site — Pueblo, Colorado, United States
• Study site — Thornton, Colorado, United States
• Study site — Niles, Illinois, United States
• Study site — Winfield, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — Columbia, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Study site — Morristown, New Jersey, United States
• Study site — Great Neck, New York, United States
• Study site — Fargo, North Dakota, United States
• Study site — Portland, Oregon, United States
• Study site — Tualatin, Oregon, United States
• Study site — Kingsport, Tennessee, United States
• Study site — Bedford, Texas, United States
• Study site — La Verne, California, United States

Full record on ClinicalTrials.gov

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