Assessment of Efficacy and Safety of Perifosine, Bortezomib and Dexamethasone in Multiple Myeloma Patients
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
1 other identifier
interventional
135
9 countries
86
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 multiple-myeloma
Started Dec 2009
Shorter than P25 for phase_3 multiple-myeloma
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2009
CompletedFirst Posted
Study publicly available on registry
October 27, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFebruary 9, 2018
March 1, 2013
3.2 years
October 23, 2009
February 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the PFS (progression free survival) in patients with multiple myeloma, treated with perifosine, bortezomib and dexamethasone compared to patients treated with placebo, bortezomib and dexamethasone
Progression-free survival will be defined as the time between randomization and the date of progression that occurred during the Core Phase.
6 - 24 months
Secondary Outcomes (3)
Overall survival (OS)
Up to 24 months
Overall response rate (ORR)
6 - 24 months
Adverse Events
Up to 24 months
Study Arms (2)
Perifosine added to combination
EXPERIMENTALPerifosine 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 Placebo added to combination
PLACEBO COMPARATORPerifosine 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).
Interventions
Perifosine will be dosed as one 50 mg pill every day of each cycle.
Perifosine placebo will be dosed as one 50 mg pill every day of each cycle.
Bortezomib will be dosed at 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days.
Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AEterna Zentarislead
- Dana-Farber Cancer Institutecollaborator
Study Sites (86)
Unknown Facility
La Verne, California, 91750, United States
Unknown Facility
San Francisco, California, 94143, United States
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San Pablo, California, 94806, United States
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Aurora, Colorado, 80012, United States
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Boulder, Colorado, 80303, United States
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Colorado Springs, Colorado, 80909, United States
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Denver, Colorado, 80218, United States
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Lakewood, Colorado, 80228, United States
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Littleton, Colorado, 80120, United States
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Longmont, Colorado, 80501, United States
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Parker, Colorado, 80138, United States
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Pueblo, Colorado, 81008, United States
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Thornton, Colorado, 80260, United States
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Niles, Illinois, 60714, United States
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Winfield, Illinois, 60190, United States
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Baltimore, Maryland, 21201, United States
Unknown Facility
Columbia, Maryland, 21044, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Unknown Facility
Morristown, New Jersey, 07960, United States
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Great Neck, New York, 11042, United States
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Fargo, North Dakota, 58122, United States
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Portland, Oregon, 97225, United States
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Tualatin, Oregon, 97062, United States
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Kingsport, Tennessee, 37660, United States
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Bedford, Texas, 76022, United States
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Dallas, Texas, 75246, United States
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Fort Worth, Texas, 76104, United States
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Kerrville, Texas, 78028, United States
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San Antonio, Texas, 78217, United States
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San Antonio, Texas, 78229, United States
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Tyler, Texas, 75702, United States
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Ogden, Utah, 84403, United States
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Christiansburg, Virginia, 24073, United States
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Roanoke, Virginia, 24014, United States
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Salem, Virginia, 24153, United States
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Seattle, Washington, 98133, United States
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Spokane, Washington, 99202, United States
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Vancouver, Washington, 98686, United States
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Milwaukee, Wisconsin, 53226, United States
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Winnipeg, Manitoba, R3E 0V9, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Québec, Quebec, G1R 2J6, Canada
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Brno, Czech Republic, 62500, Czechia
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Prague, Czech Republic, 12821, Czechia
Keryx / AOI Pharmaceuticals Investigative Site
Dublin, Ireland
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Dublin, Ireland
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Galway, Ireland
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Limerick, Ireland
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Sligo, Ireland
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Tullamore, Ireland
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Waterford, Ireland
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Afula, 18101, Israel
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Ashkelon, 78278, Israel
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Beersheba, 84101, Israel
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Haifa, 31096, Israel
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Jerusalem, 91031, Israel
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Jerusalem, 91120, Israel
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Nahariya, 22100, Israel
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Petah Tikva, 49100, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 64239, Israel
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Tel Litwinsky, 52621, Israel
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Moscow, 125284, Russia
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Moscow, 129110, Russia
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Saint Petersburg, 191024, Russia
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Saint Petersburg, 197022, Russia
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Samara, 443095, Russia
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Košice, Slovak Republic, 04166, Slovakia
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Seoul, 110-744, South Korea
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Seoul, 120-752, South Korea
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Seoul, 135-710, South Korea
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Seoul, 137-701, South Korea
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Seoul, 138-736, South Korea
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Badalona, 08916, Spain
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Barcelona, 08025, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Madrid, 28006, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Pamplona, 31008, Spain
Unknown Facility
San Cristóbal de La Laguna, 38320, Spain
Unknown Facility
Valencia, 46026, Spain
Unknown Facility
Zaragoza, 50009, Spain
Related Publications (1)
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
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Richardson, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2009
First Posted
October 27, 2009
Study Start
December 1, 2009
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
February 9, 2018
Record last verified: 2013-03