NCT00781170已完成2 期
Dose-Reduced Allogeneic Stem Cell Transplantation as Induction of a Graft-Versus-Myeloma-Effect After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma Stage II/III
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Safety and efficacy of a conditioning regimen with Fludarabine, Melphalan and ATG prior allogeneic SCT after high dose chemotheraoie and autologous SCT. Evaluation of underlying disease and donor-recipient-chimerism.
研究概览
简要总结
To evaluate the feasibility and efficacy of a autologous stem cell transplantation followed by a Melphalan/ Fludarabine based dose-reduced allograft from HLA-identical and HLA-compatible unrelated donor in patients with Multiple Myeloma. In those with non complete remission DLI and/ or new agents such as Bortezomib, Thalidomid or Lenalidomide can be used to upgrade remission.
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 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple Myeloma Stadium II / III acc. to Salmon and Durie
- •signed informed consent
- •adequate organ function prior autologous respectively allogeneic SCT
- •availability of HLA-identical related or unrelated donor
- •availability of at least 2 x 10^6 CD34+ cells per kg BW of recipient for the autologous SCT and at least 3 x 10^6 CD34+ cells for allogeneic SCT
- •for MRD-SCT: 18-66 years; for MUD-SCT: 18-55 years
- •at age <55 years existence of risk factors that make an myeloablative allogeneic transplantation to risky
- •consent of donor to give DLI
排除标准
- •severe heart insufficiency
- •cardiovascular diseases or severe concomitant diseases
- •active infections that need antibiotic therapy
- •positive for HIV or hepatitis
- •malign secondary disease
- •limited liver function with total bilirubin > 1.5 ULN
- •increased transaminase > 3 ULN
- •increased serum creatinine > 2 mg/dl
- •pregnant or lactating women
- •known hypersensitivity to Fludarabine or Melphalan
- •participation in another trial
结局指标
主要结局
Safety and efficacy of a conditioning regimen with Fludarabine, Melphalan and ATG prior allogeneic SCT after high dose chemotheraoie and autologous SCT. Evaluation of underlying disease and donor-recipient-chimerism.
次要结局
- Evaluation of engraftment of leucocytes and platelets
- Evaluation of the effects of DLI in case of no CR
- Evaluation of disease-free and overall survival
- Evaluation of incidence of acute and chronic GvHD
- Evaluation of infectious complications
研究者
相似试验
尚未招募
不适用
Allogeneic Stem Cell Transplantation after Reduced Intensity Conditioning for High- risk Relapsed or Refractory CLLA prospective multi-centre phase II studyRefractory or relapsed Chronic Lymphocytic LeukemiaNL-OMON27777Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 7041560Fax: 010 7041028e-mail: hdc@erasmusmc.nl50
已完成
2 期
Reduced Intensity Stem Cell Transplantation in Children With Relapsed Neuroblastoma After Autologous TransplantationNeuroblastomaNCT00793351Samsung Medical Center25
已完成
2 期
Risk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Non-Malignant DiseasesSevere Combined ImmunodeficiencyBone Marrow FailureOsteopetrosisFanconi AnemiaNCT01019876Columbia University38
Unknown
1 期
Stem Cell Transplantation for the Treatment of Knee OsteoarthritisKnee OsteoarthritisNCT00550524Tehran University of Medical Sciences5
已完成
2 期
Stem Cell Transplantation in Patients With High-Risk and Recurrent Pediatric SarcomasSarcomaNCT00043979National Cancer Institute (NCI)60