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临床试验/EUCTR2016-004778-16-AT
EUCTR2016-004778-16-AT进行中(未招募)1 期

Carfilzomib in combination with lenalidomide and dexamethasone – feasibility and efficacy of a new consolidation regimen in inducing and/or re-inducing minimal residual disease negativity in multiple myeloma patients after a first autologous stem cell transplant. A prospective, multicenter, interventional, open label, phase II Trial.

Department of Medicine I, Ordensklinikum Linz, Elisabethinen Hospital Linz0 个研究点目标入组 41 人开始时间: 2017年12月19日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
41

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

  • - Anteceding therapeutic sequence of 4 to 6 cycles of an induction therapy followed by a treatment with high-dose melphalan (HD-MEL) and ASCT
  • - = partial response before HD-MEL
  • - = very good partial response and MRD-positivity after ASCT
  • 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 21
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • One or more of the following ultra-high risk features at first diagnosis:
  • - A Revised International Staging System (R-ISS) score (Palumbo 2015) of III at first diagnosis
  • - Extended extramedullary disease (especially CNS involvement)
  • - Plasma cell leukemia

研究者

发起方
Department of Medicine I, Ordensklinikum Linz, Elisabethinen Hospital Linz

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