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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Outcome Time Frame:

6 - 24 months

Safety Issue:

No

Principal Investigator

Paul Richardson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

Perifosine 339

NCT ID:

NCT01002248

Start Date:

December 2009

Completion Date:

March 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Relapsed multiple myeloma
  • Refractory multiple myeloma
  • Relapsed refractory multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Hinsdale, Illinois  60521
Fountain Valley, California  92708
Albany, New York  12208
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
McLean, Virginia  22101
Hackensack, New Jersey  07601
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Denver, Colorado  
Baltimore, Maryland  21287
Eugene, Oregon  
Milwaukee, Wisconsin  
Bismarck, North Dakota  58501
Salt Lake City, Utah  84112