Back to resultsAssessment of Efficacy and Safety of Perifosine, Bortezomib and Dexamethasone in Multiple Myeloma Patients
Primary Purpose
Multiple Myeloma
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Perifosine
Perifosine Placebo
Bortezomib
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Relapsed multiple myeloma, Refractory multiple myeloma, Relapsed refractory multiple myeloma
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.
Sites / Locations
- Dana Farber Cancer Institute
- Keryx / AOI Pharmaceuticals Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Perifosine added to combination
Perifosine Placebo added to combination
Arm Description
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 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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall survival (OS)
OS is defined as time from randomization to death from any cause during the Core Phase of the study.
Overall response rate (ORR)
The ORR for each treatment arm will be estimated as the proportion of responders, defined as a patient whose best overall response is PR or better during the treatment period, using criteria prospectively established.
Adverse Events
Each AE and SAE term submitted will be mapped to a preferred term (PT) using the MedDRA dictionary. The investigator will classify the severity of AEs using the NCI CTCAE v3.0 and will assess the relationship of each event to each study treatment.
Full Information
NCT ID
NCT01002248
First Posted
October 23, 2009
Last Updated
February 6, 2018
Sponsor
AEterna Zentaris
Collaborators
Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT01002248
Brief Title
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
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AEterna Zentaris
Collaborators
Dana-Farber Cancer Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Relapsed multiple myeloma, Refractory multiple myeloma, Relapsed refractory multiple myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perifosine added to combination
Arm Type
Experimental
Arm Description
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).
Arm Title
Perifosine Placebo added to combination
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Perifosine
Other Intervention Name(s)
D-21266, KRX-0401
Intervention Description
Perifosine will be dosed as one 50 mg pill every day of each cycle.
Intervention Type
Drug
Intervention Name(s)
Perifosine Placebo
Intervention Description
Perifosine placebo will be dosed as one 50 mg pill every day of each cycle.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
Bortezomib will be dosed at 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
Primary Outcome Measure Information:
Title
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
Description
Progression-free survival will be defined as the time between randomization and the date of progression that occurred during the Core Phase.
Time Frame
6 - 24 months
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
OS is defined as time from randomization to death from any cause during the Core Phase of the study.
Time Frame
Up to 24 months
Title
Overall response rate (ORR)
Description
The ORR for each treatment arm will be estimated as the proportion of responders, defined as a patient whose best overall response is PR or better during the treatment period, using criteria prospectively established.
Time Frame
6 - 24 months
Title
Adverse Events
Description
Each AE and SAE term submitted will be mapped to a preferred term (PT) using the MedDRA dictionary. The investigator will classify the severity of AEs using the NCI CTCAE v3.0 and will assess the relationship of each event to each study treatment.
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Richardson, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
City
La Verne
State/Province
California
ZIP/Postal Code
91750
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
City
San Pablo
State/Province
California
ZIP/Postal Code
94806
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
City
Parker
State/Province
Colorado
ZIP/Postal Code
80138
Country
United States
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81008
Country
United States
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80260
Country
United States
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
City
Great Neck
State/Province
New York
ZIP/Postal Code
11042
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98686
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
City
Brno
State/Province
Czech Republic
ZIP/Postal Code
62500
Country
Czechia
City
Prague
State/Province
Czech Republic
ZIP/Postal Code
12821
Country
Czechia
City
Dublin 24
Country
Ireland
Facility Name
Keryx / AOI Pharmaceuticals Investigative Site
City
Dublin 7
Country
Ireland
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
ZIP/Postal Code
18101
Country
Israel
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
City
Saint Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
City
Kosice
State/Province
Slovak Republic
ZIP/Postal Code
04166
Country
Slovakia
City
Badalona
ZIP/Postal Code
08916
Country
Spain
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
La Laguna
ZIP/Postal Code
38320
Country
Spain
City
Madrid
ZIP/Postal Code
28006
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
City
Valencia
ZIP/Postal Code
46026
Country
Spain
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Citations:
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
Results Reference
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Learn more about this trial
Assessment of Efficacy and Safety of Perifosine, Bortezomib and Dexamethasone in Multiple Myeloma Patients
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