跳至主要内容
临床试验/NCT00466674
NCT00466674已完成2 期

Treatment of Myeloma in Patients <= 65 Years Old With Response >= 50% After HSC Autotransplant by Allogenic Transplant Genoidentical or Phenoidentical After Reduced Intensity Conditioning (IFM 2005-03)

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2007年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
13
试验地点
1
主要终点
Improvement of 15% of Event-free survival (EFS) at 3 years after allo HSCT (decrease of the number of deaths and progressions).

研究概览

简要总结

Donor mobilization :

Donor will be mobilized with G-CSF (Granocyte) sub-cutaneous 10 µg/kg/day during 5 to 6 days.

Hematopoïetic Stem Cell Harvest:

By 1, 2, or 3 aphaeresis, a number of 4 x 106 cellules CD34+ /kg is required. If the CD34+ >= 2 and <= 4x106/kg: the center must decide on the strategy Decision. In case of insufficient graft : a Bone Marrow Harvest is recommended Conditioning : Fludarabine - Busulfan - ATG

  • D-5 : Fludarabine (30 mg/m²)
  • D-4 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h)
  • D-3 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h)
  • D-2 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg)
  • D-1 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg) GVHD Prophylaxis: CsA alone at 3 mg/ kg + Methotrexate D1, D3 and D6 only in case of minor ABO incompatibility and with an anti A/B antibodies titer> 1/32.

Transplant : HSC at D0

• 3 months after Transplantation :

Disease Evaluation :

  • If CR : Supervision. Then if progression: 4 cycles of Bortezomib.
  • If no CR : Bortezomib (4 cycles)

• Evaluation after Bortezomib cycles

  • If CR : Supervision. Then, if progression and no GvHD : DLI If no RC and no GVHD : DLI

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

  • Major patients not under guardianship
  • Myeloma with high b2 microglobulin level (> 3 mg/l) and/or chromosome 13 deletion, and/or translocation t(4;14) stage I DS with high evolutive potential or stage II, III DS.
  • With response >= 50% and <= 90% after the first AutoHSCT (IFM 2005 01). The evaluation must be performed within 2 months after the first AutoHSCT.
  • with an HLA identical related or unrelated donor ( match 10/10).
  • Donor and recipient must have signed a written informed consent.

排除标准

  • 未提供

研究组 & 干预措施

Allogenic Transplant

Experimental

干预措施: reduced intensity conditioning (Drug)

结局指标

主要结局

Improvement of 15% of Event-free survival (EFS) at 3 years after allo HSCT (decrease of the number of deaths and progressions).

时间窗: 3 years

次要结局

  • The tolerance of Bortezomib after AlloHCST(5 years)
  • Haematological recovery(3 years)
  • Engraftment rate and graft failure rate(3 years)
  • CR (Complete Response) length rate defined by Bladé criteria.(5 years)
  • Incidence and severity of acute and chronic GVHD(5 years)
  • Outcome of GVHD under treatment by Bortezomib(5 years)
  • Chimerism study by competitive PRC(5 years)
  • Immunological study of the graft (ancillary study)(5 years)
  • Study of immunological recovery by the recipient(5 years)
  • TRM = Transplant- Related Mortality at 3 months(3 months)
  • TRM = Transplant- Related Mortality at 1 year(1 year)
  • Study of quality of life(5 years)
  • Global survival at 3 years and 5 years(3 and 5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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