A clinical study to investigate whether perifosine is effective and safe in treating patients with multiple myeloma when combined with bortezomib (Velcade®) and dexamethasone

• Conditions: Multiple myeloma; MedDRA version: 15.0Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-018893-19-IE
• Lead Sponsor: Aeterna Zentaris GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-11
• Last Update Posted: 1 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Patients with a confirmed diagnosis of relapsed or relapsed/refractory multiple myeloma that are currently progressing or have recently relapsed.

• Measurable disease (serum M-protein >0.5g/dl and/or >200mg urinary M-protein excretion).

• Patients must have relapsed (progressed > 60 days) after their last dose of bortezomibbased therapy. In addition, patients may be refractory to (progressing on or within 60 days of discontinuing therapy) or relapsed from other non-bortezomib-based therapies.

• Patients must have previously received at least two cycles of either single agent bortezomib treatment (21 day cycle) at the 1.3 mg/m2 dose or a minimum of 1.0 mg/m2 if used in combination with other active agents or in patients with underlying neuropathy.

• Patients must have previously received at least one cycle (minimum of 21 days) of an immunomodulatory agent (e.g. thalidomide, lenalidomide). There is no prior minimum dose requirement for a prior immunomodulatory agent.

• Patients must have received at least two anti-myeloma drugs (which must include bortezomib and an immunomodulatory agent). Patients may have received one prior anti-myeloma regimen which is required to contain a combination of bortezomib and an immunomodulatory agent. Therefore, patients must have received at least one and no more than four prior anti-myeloma regimens and have progressive disease after the most recent treatment regimen. (Multiple lines of therapy may be most easily delineated by at least disease stabilization followed by a change in therapy due to progression).

• Patient must be willing and able to participate in PK sampling.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 225
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225

Exclusion Criteria

• Patients refractory to any regimen containing bortezomib.

• Patients with non-secretory multiple myeloma. (myeloma where the malignant plasma cells do not secrete M protein or light chains).

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Comparison of perifosine to placebo with respect to progression-free survival (PFS) in relapsed or relapsed/refractory multiple myeloma patients receiving bortezomib and dexamethasone.;Secondary Objective: 1) comparison of perifosine to placebo with respect to overall response rate (ORR = partial response [PR] or better), overall survival (OS), and time to progression (TTP) in multiple myeloma patients receiving bortezomib and dexamethasone<br><br>2) Evaluation of the safety of the combination of perifosine, bortezomib, and dexamethasone compared to placebo, bortezomib, and dexamethasone.;Primary end point(s): Progression free survial. ;Timepoint(s) of evaluation of this end point: The analysis, which is event-based, will be conducted after approximately 265 randomized patients have progressed or died.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Comparison of perifosine to placebo with respect to an overall response rate (partial response [PR] or better), overall survival, and time to progression (TTP) <br><br>2. Evaluation of the safety of the combination of perifosine, bortezomib, and dexamethasone compared to placebo, bortezomib, and dexamethasone.;Timepoint(s) of evaluation of this end point: The analysis, which is event-based, will be conducted after approximately 265 randomized patients have progressed or died.