EUCTR2009-012033-30-GB进行中（未招募）1 期
Phase II Study of the Adjunctive Use of Lenalidomide in Patients Undergoing Reduced Intensity Conditioning Allogeneic Transplantation for Multiple Myeloma - Post Transplant Lenalidomide for Multiple Myeloma (Version 1)
niversity Hospitals Birmingham NHS Foundation Trust0 个研究点目标入组 40 人开始时间: 2010年8月18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
- 40
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
- •Inclusion Criteria
- •Multiple myeloma subjects who have received a high dose melphalan conditioned autologous transplant in the preceding 180 days and who are in CR1 or VGPR1 after their first line of treatment or CR2 or VGPR2 after treatment of first relapse. CR/VGPR are as defined by International uniform response criteria for Myeloma, 2006 (appendix 1). VGPR for non-secretory myeloma is not defined in this criteria. For this study VGPR in non-secretory myeloma patients is defined as a 90% reduction in plasma cells, provided there were 30% or more plasma cells at diagnosis.
- •Patients >18 years and =70 years in whom allogeneic transplantation using a reduced intensity conditioning regimen is not contra-indicated but who are not suitable for conventional allograft
- •ECOG status ?2 or an ECOG status of 3 if the reason for a status of 3 is due exclusively to multiple myeloma (e.g. pathological fracture) (Appendix 2)
- •Patients with a HLA identical related or ten/ten antigen (A,B,C,DQ,DR) matched unrelated donor
- •Cardiac ejection fraction > 40%. Or report stating left ventricular function is satisfcatory or normal
- •Creatinine clearance >50 ml/min
- •Liver function (AST or ALT) < 2.5 x upper limit of normal
- •Patients able to give written informed consent prior to allogeneic transplant, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
- •Patients willing and able to comply with the protocol for the duration of the study
- •Agree to abstain from donating blood (and semen in male subjects) while taking study drug therapy and for 28 days following discontinuation of study drug therapy
- •Agree not to share study drug with another person and to return all unused study drug to the investigator or pharmacist
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients with allergies or contraindications to receiving fludarabine, Lenalidomide, ciclosporin or ATG
- •Patients with a known positive serology for HIV/Hepatitis B/Hepatitis C
- •Patients who have undergone a previous allogeneic stem cell transplant
- •Patients who have previously progressed on Lenalidomide
- •Pregnant or lactating women
- •Adults of reproductive potential not willing to comply with the Lenalidomide Risk Minimisation Plan (see below for details)
- •Patients with organ allografts
- •Any co-morbidity that, in the investigators opinion, would affect the patient’s participation in this study
- •Patients who have taken any other investigational medical product within 4 weeks of starting conditioning therapy
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