EUCTR2016-002557-38-DE进行中（未招募）1 期
Cyclophosphamide as graft-versus-host prophylaxis after allogeneic stem celltransplantation for multiple myeloma. A phase II study.
niversity Medical Center Hamburg-Eppendorf0 个研究点目标入组 50 人开始时间: 2017年10月9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
- 50
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
- •- Multiple myeloma newly diagnosed with deletion 17p or translocation
- •4;14 or multiple myeloma with 1. or 2. relapse after autologous
- •stem cell transplantation
- •- Patients age: 18 - 65 years at time of inclusion (female and
- •-Performance status ECOG < 2
- •- Availability of haploidentical, matched or mismatched relative or
- •unrelated donor
- •- Patients understand and voluntarily sign an informed consent
- •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 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Multiple Myeloma newly diagnosed patients without detection of deletion 17p or translocation 4;14
- •-Severe active infection or other uncontrolled severe condition-ing
- •-Severe renal, hepatic, pulmonary or cardiac disease, such as:
- •Total bilirubin, SGPT or SGOT > 3 times upper the normal level
- •Left ventricular ejection fraction < 30 %
- •Creatinine clearance < 30 ml/min
- •DLCO < 35 % and/or receiving supplementary continuous ox-ygen
- •-Positive serology for HIV
- •-Pregnant or lactating women (positive serum pregnancy test)
- •-Age < 18 and > 65 years.
- •-Uncontrolled invasive fungal infection at time of screening (baseline)
- •-Serious psychiatric or psychological disorders
- •-Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment
研究者
相似试验
尚未招募
2 期
Thalassemia study with stem cellsCTRI/2018/07/014826Christian Medical College Vellore
已完成
3 期
Post -transplantation Cyclophosphamide as Graft Versus Host Disease prophylaxis in Children with ß-Thalassemia Major undergoing Hematopoietic Stem Cell TransplantatioPACTR202311877246623faculty of medicine tanta university30
已完成
2 期
Cyclophosphamide As Graft-versus-host Prophylaxis After Allogeneic Stem Cell Transplantation for Multiple MyelomaMultiple MyelomaNCT03700450Universitätsklinikum Hamburg-Eppendorf37
进行中（未招募）
不适用
evaluation of toxicity and efficacy of a transplantation program with high dose cyclophosphamide post transplant as GVHD prophylaxis in patients who underwent to allo transplant after RIC.Elderly patients (66-70 years) with acute leukemia or high-risk MDS who, underwent allogenic transplant of peripheral hematopoietic progenitors after reduced-intensity conditioning.MedDRA version: 15.1Level: LLTClassification code 10018653Term: Graft-versus-host disease <GVHD>System Organ Class: 100000004870EUCTR2012-004118-33-ITAZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)
进行中（未招募）
3 期
GvHD Prophylaxis in Unrelated Donor HCT: Randomized Trial Comparing PTCY Versus ATGGraft Vs Host DiseasePeripheral Blood Stem Cell TransplantationMDS/MPNAMLMDSCMMLNCT05153226DKMS gemeinnützige GmbH640