NL-OMON36688已完成2 期
A randomized phase II study for the 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
HOVO0 个研究点目标入组 110 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Patients with multiple myeloma with a first relapse or 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
- •- WHO-performance status 0-2;
- •- Written informed consent
排除标准
- •- No previous Allo-SCT;
- •- Severe pulmonary dysfunction (CTCAE grade III-IV, see protocol 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
- •- 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 protocol appendix E).
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