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

AEterna Zentaris

Status and phase: Terminated; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Bortezomib; Drug: Dexamethasone; Drug: Perifosine Placebo; Drug: Perifosine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01002248

Perifosine 339

Details and patient eligibility

About

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.

Full description

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

Enrollment: 135 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 2 patient groups, including a placebo group

Perifosine added to combination

Experimental group

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).

Treatment:

Drug: Perifosine

Drug: Bortezomib

Drug: Dexamethasone

Perifosine Placebo added to combination

Placebo Comparator group

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).

Treatment:

Drug: Bortezomib

Drug: Perifosine Placebo

Drug: Dexamethasone