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)
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
- 否
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
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)
