跳至主要内容
临床试验/NCT01665014
NCT01665014Unknown2 期

Efficacy and Safety of Double Autologous Hematopoietic Stem Cell Transplantation With Sequential Use of Total Marrow Irradiation and High-dose Melphalan in Multiple Myeloma

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年8月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
50
试验地点
2
主要终点
Progression-free survival

研究概览

简要总结

The purpose of this study is to evaluate if the use total marrow irradiation (TMI) as a sole preparation for the first autologous hematopoietic stem cell transplantation (autoHSCT) followed by high-dose melphalan used prior to second autoHSCT is safe and effective in patients with multiple myeloma (MM).

详细描述

AutoHSCT is a standard treatment of patients with MM. According to soem clinical evidence double autoHSCT provides survival advantage compared to a single procedure. Most frequently used conditioning regimen consists pf high doses of melphalan (HD-MEL). In some studies it was used in combination with total body irradiation (TBI), which, however was associated with significant toxicity. In our center the standard procedure includes TBI as a single treatment at 1st autoHSCT and HD-Mel at 2nd autoHSCT.

As in MM malignant plasma cells are localized almost exclusively in bone marrow there is rationale to limit irradiation to bones. For this purpose in the current study we substitute TBI with TMI. Additional boosts are provided for active sites of disease based on PET/CT imaging. Our intention is to minimize toxicity while maintaining the treatment efficacy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-65 years
  • Diagnosis of multiple myeloma
  • PR, VGPR or CR at inclusion
  • Performance status WHO 0-1
  • Written informed consent

排除标准

  • Organ dysfunction: elevated ALT, AST, bilirubin, AF; creatinine >1.5 upper normal limit; LVEF <45%
  • Active infection
  • Unstable diabetes
  • Psychiatric diseases
  • History of high-dose chemotherapy or irradiation
  • Second malignancy
  • Pregnancy

结局指标

主要结局

Progression-free survival

时间窗: three years

次要结局

  • Rate of complete and very good partial responses(six months)

研究者

发起方
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
申办方类型
Other
责任方
Sponsor

研究点 (2)

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