EUCTR2010-018893-19-SK进行中（未招募）不适用
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
AOI Pharmaceuticals, Inc.0 个研究点目标入组 450 人开始时间: 2010年12月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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