Assessment of Efficacy and Safety of Perifosine, Bortezomib and Dexamethasone in Multiple Myeloma Patients
NCT ID: NCT01002248
Last Updated: 2018-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
135 participants
INTERVENTIONAL
2009-12-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Perifosine added to combination
Perifosine added to the combination of Bortezomib and Dexamethasone. Perifosine is is supplied as a film-coated tablet containing 50 mg of active ingredient. Perifosine will be administered orally on an outpatient basis throughout the study. Daily administration will be one 50 mg tablet.
The first dose of perifosine should be taken on the same day that bortezomib and dexamethasone are administered (Cycle 1 Day 1).
Perifosine
Perifosine will be dosed as one 50 mg pill every day of each cycle.
Bortezomib
Bortezomib will be dosed at 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days.
Dexamethasone
Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
Perifosine Placebo added to combination
Perifosine placebo added to the combination of Bortezomib and Dexamethasone. The placebo for perifosine is provided in 256 mg white to off-white, round, biconvex film-coated tablets to permit a blinded trial with perifosine 50 mg film coated tablets. Placebo will be administered orally on an outpatient basis throughout the study. Daily administration will be one perifosine placebo tablet. The first dose of placebo should be taken on the same day that bortezomib and dexamethasone are administered (Cycle 1 Day 1).
Perifosine Placebo
Perifosine placebo will be dosed as one 50 mg pill every day of each cycle.
Bortezomib
Bortezomib will be dosed at 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days.
Dexamethasone
Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
Interventions
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Perifosine
Perifosine will be dosed as one 50 mg pill every day of each cycle.
Perifosine Placebo
Perifosine placebo will be dosed as one 50 mg pill every day of each cycle.
Bortezomib
Bortezomib will be dosed at 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days.
Dexamethasone
Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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.
18 Years
ALL
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
AEterna Zentaris
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Richardson, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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La Verne, California, United States
San Francisco, California, United States
San Pablo, California, United States
Aurora, Colorado, United States
Boulder, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Lakewood, Colorado, United States
Littleton, Colorado, United States
Longmont, Colorado, United States
Parker, Colorado, United States
Pueblo, Colorado, United States
Thornton, Colorado, United States
Niles, Illinois, United States
Winfield, Illinois, United States
Baltimore, Maryland, United States
Columbia, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Morristown, New Jersey, United States
Great Neck, New York, United States
Fargo, North Dakota, United States
Portland, Oregon, United States
Tualatin, Oregon, United States
Kingsport, Tennessee, United States
Bedford, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Kerrville, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Ogden, Utah, United States
Christiansburg, Virginia, United States
Roanoke, Virginia, United States
Salem, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Vancouver, Washington, United States
Milwaukee, Wisconsin, United States
Winnipeg, Manitoba, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Brno, Czech Republic, Czechia
Prague, Czech Republic, Czechia
Keryx / AOI Pharmaceuticals Investigative Site
Dublin, , Ireland
Dublin, , Ireland
Galway, , Ireland
Limerick, , Ireland
Sligo, , Ireland
Tullamore, , Ireland
Waterford, , Ireland
Afula, , Israel
Ashkelon, , Israel
Beersheba, , Israel
Haifa, , Israel
Jerusalem, , Israel
Jerusalem, , Israel
Nahariya, , Israel
Petah Tikva, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Tel Litwinsky, , Israel
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Košice, Slovak Republic, Slovakia
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Badalona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Pamplona, , Spain
San Cristóbal de La Laguna, , Spain
Valencia, , Spain
Zaragoza, , Spain
Countries
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References
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Richardson PG, Nagler A, Ben-Yehuda D, Badros A, Hari P, Hajek R, Spicka I, Kaya H, Le Blanc R, Yoon SS, Kim K, Martinez-Lopez J, Mittelman M, Shpilberg O, Tothova E, Laubach JP, Ghobria IM, Leiba M, Gatt ME, Sportelli P, Chen M, Anderson KC. Randomized Placebo-Controlled Phase III Study Of Perifosine Combined With Bortezomib and Dexamethasone In Relapsed, Refractory Multiple Myeloma Patients Previously Treated With Bortezomib. Blood 2013 ASH Meeting Proceedings;122:abstract 3189
Other Identifiers
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Perifosine 339
Identifier Type: -
Identifier Source: org_study_id
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