EUCTR2010-018893-19-CZ进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 225
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 225
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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