Clinical trial NCT01002248: Assessment of Efficacy and Safety of Perifosine, Bortezomib and Dexamethasone in Multiple Myeloma Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Relapsed multiple myeloma
Refractory multiple myeloma
Relapsed refractory multiple myeloma
Lead sponsor: AEterna Zentaris
Sponsor class: INDUSTRY
Collaborators: name: Dana-Farber Cancer Institute
First posted: 2009-10-27
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: A pre-planned interim analysis is expected to take place in Q1 of 2013.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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
timeFrame: 6 - 24 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 24 months
measure: Overall response rate (ORR)
timeFrame: 6 - 24 months
measure: Adverse Events
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: La Verne
country: United States
state: California
city: San Francisco
country: United States
state: California
city: San Pablo
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Boulder
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Lakewood
country: United States
state: Colorado
city: Littleton
country: United States
state: Colorado
city: Longmont
country: United States
state: Colorado
city: Parker
country: United States
state: Colorado
city: Pueblo
country: United States
state: Colorado
city: Thornton
country: United States
state: Colorado
city: Niles
country: United States
state: Illinois
city: Winfield
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Columbia
country: United States
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Morristown
country: United States
state: New Jersey
city: Great Neck
country: United States
state: New York
city: Fargo
country: United States
state: North Dakota
city: Portland
country: United States
state: Oregon
city: Tualatin
country: United States
state: Oregon
city: Kingsport
country: United States
state: Tennessee
city: Bedford
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Kerrville
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Ogden
country: United States
state: Utah
city: Christiansburg
country: United States
state: Virginia
city: Roanoke
country: United States
state: Virginia
city: Salem
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Vancouver
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Winnipeg
country: Canada
state: Manitoba
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Brno
country: Czechia
state: Czech Republic
city: Prague
country: Czechia
state: Czech Republic
city: Dublin 24
country: Ireland
city: Dublin 7
country: Ireland
facility: Keryx / AOI Pharmaceuticals Investigative Site
city: Dublin 8
country: Ireland
city: Dublin 9
country: Ireland
city: Galway
country: Ireland
city: Limerick
country: Ireland
city: Sligo
country: Ireland
city: Tullamore
country: Ireland
city: Waterford
country: Ireland
city: Afula
country: Israel
city: Ashkelon
country: Israel
city: Beer Sheva
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Jerusalem
country: Israel
city: Nahariya
country: Israel
city: Petah Tikva
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Tel-Hashomer
country: Israel
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Samara
country: Russian Federation
city: Kosice
country: Slovakia
state: Slovak Republic
city: Badalona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: La Laguna
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Pamplona
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Paul Richardson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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