EUCTR2010-018494-37-NL进行中（未招募）不适用
A randomized phase II study for evaluation of T cell depleted non myeloablative allogeneic stem cell transplantation followed by early consolidation with lenalidomide or lenalidomide combined with bortezomib and subsequent DLI for patients with multiple myeloma in progression or relapse following first line therapy - HO108 MM
HOVON Foundation0 个研究点开始时间: 2010年8月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Patients with multiple myeloma with a first relapse or with progression after first line therapy;
- •Relapsed or progressive patients have received reinduction therapy before entering this trial;
- •At least PR after reinduction treatment;
- •18-65 years,inclusive;
- •HLA-identical sibling or unrelated donor completely matched (10/10) (excluding identical twins);
- •WHO-performance status 0-2;
- •Written 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 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •No previous Allo-SCT;
- •Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);
- •Severe neurological or psychiatric disease;
- •Patients with neuropathy, CTC grade 3 or higher;
- •Significant hepatic dysfunction (serum bilirubin or transaminases = 3 times upper limit of normal);
- •Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration);
- •Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.);
- •History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or or carcinoma in situ” of the cervix or breast;
- •Patient known to be HIV-positive;
- •Patients with brain disease with the exception of those patients whose brain disease has been treated with either radiotherapy or surgery and remains asymptomatic, with no active brain disease, as shown by CT scan or MRI, for at least 6 months;
- •The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide or borium;
- •Pregnant or breast-feeding female patients. Negative pregnancy test at study is mandatory for female patients of childbearing potential;
- •Not able and not willing to use adequate contraception during therapy;
- •Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
- •Severe cardiac dysfunction (NYHA classification II-IV, see appendix E).
研究者
相似试验
招募中
2 期
Dose escalation trial for squamous cell carcinoma of head and neck using FMISO PET CTCTRI/2024/04/065373Varian Medical Systems Inc
进行中（未招募）
不适用
Safety and immunogenicity study of GSK Biologicals' malaria vaccine 257049, when incorporated into an EPI regimen.Primary immunization against Plasmodium falciparum malaria in healthy male and female infants aged 6 to 10 weeks at first vaccine dose, if eligible according to inclusion and exclusion criteria.EUCTR2012-005695-34-Outside-EU/EEAGlaxoSmithKline Biologicals511
已完成
不适用
An exploratory study of dignity therapy for older people in care homesISRCTN37589515King's College London (UK)64
已完成
2 期
An exploratory study of Dignity Therapy for people with advanced cancerAdvanced cancerMalignant neoplasm of other and ill-defined sitesCancerISRCTN29868352King's College London (UK)40
已完成
2 期
A randomized controlled Phase II study comparing TS-1 alone with CDDP+TS-1 as postoperative adjuvant chemotherapy in non-small-cell-lung-cancer ; translational research of the chemotherapy effect prediction factoron Small Cell Lung CancerJPRN-UMIN000001658West Japan Oncology Group200