A Phase III Randomized Study to Assess the Efficacy and Safety of Perifosine Added to the Combination of Bortezomib and Dexamethasone in Multiple MyelomaPatients Previously Treated with Bortezomib
- Conditions
- Multiple MyelomaMedDRA version: 12.1Level: PTClassification code 10028228Term: Multiple myeloma
- Registration Number
- EUCTR2010-018893-19-SK
- Lead Sponsor
- AOI Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
• 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 therapies (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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• 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 perifosine to placebo with respect to an overall response<br>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. The analysis, which is event-based, will be conducted after approximately 265 randomized patients have progressed or died.
- Secondary Outcome Measures
Name Time Method