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

This study has been terminated.
Sponsor:
Collaborator:
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
AEterna Zentaris
ClinicalTrials.gov Identifier:
NCT01002248
First received: October 23, 2009
Last updated: February 14, 2014
Last verified: March 2013
History of Changes
October 23, 2009
February 14, 2014
December 2009
March 2013   (Final data collection date for primary outcome 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 [ Time Frame: 6 - 24 months ]
Progression-free survival [ Time Frame: q 3 weeks ]
Complete list of historical versions of study NCT01002248 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: Up to 24 months ]
  • Overall response rate [ Time Frame: 6 - 24 months ]
  • Adverse Events [ Time Frame: Up to 24 months ]
  • Overall survival [ Time Frame: q 3 weeks ]
  • Overall response rate [ Time Frame: q 3 weeks ]
  • Adverse Events [ Time Frame: q 3 weeks ]
Not Provided
Not Provided
 
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
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.
A pre-planned interim analysis is expected to take place in Q1 of 2013.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: Perifosine
    Perifosine will be dosed as one 50 mg pill every day of each cycle.
  • Drug: Perifosine Placebo
    Perifosine placebo will be dosed as one 50 mg pill every day of each cycle.
  • Drug: Bortezomib
    Bortezomib will be dosed at 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days.
  • Drug: 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.
  • Experimental: Perifosine + Bortezomib + Dexamethasone
    Interventions:
    • Drug: Perifosine
    • Drug: Bortezomib
    • Drug: Dexamethasone
  • Placebo Comparator: Placebo + Bortezomib + Dexamethasone
    Interventions:
    • Drug: Perifosine Placebo
    • Drug: Bortezomib
    • Drug: Dexamethasone
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
135
March 2013
March 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Czech Republic,   Ireland,   Israel,   Korea, Republic of,   Russian Federation,   Slovakia,   Spain,   United States
 
 
NCT01002248
Perifosine 339
Yes
Not Provided
Not Provided
AEterna Zentaris
AEterna Zentaris
Dana-Farber Cancer Institute
Principal Investigator: Paul Richardson, MD Dana-Farber Cancer Institute
AEterna Zentaris
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP