ISRCTN16228367已完成2 期
Phase II study of the adjuvant use of lenalidomide in patients undergoing reduced intensity conditioning allogenic transplantation for multiple myeloma
niversity Hospitals Birmingham NHS Foundation Trust (UK)0 个研究点目标入组 40 人开始时间: 2011年5月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
- 性别
- All
入选标准
- •1. Multiple myeloma subjects who have received a high dose melphalan conditioned autologous transplant in the preceding 120 days and who are in CR1/2 or VGPR1/2 as defined by International uniform response criteria for Myeloma, 2006 (Appendix 1)
- •2. Patients 18 to 70 years in whom allogeneic transplantation using a reduced intensity conditioning regimen is not contra-indicated but who are not suitable for conventional allograft
- •3. Eastern Cooperative Oncology Group (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)
- •4. Patients with a HLA identical sibling or ten/ten antigen (A,B,C,DR,DQ) matched unrelated donor
- •5. Cardiac ejection fraction > 40%
- •6. Measured EDTA Creatinine clearance >50 ml/min
- •7. Carbon Monoxide Diffusing Capacity (DLCO) >50%
- •8. Liver function (AST or ALT) < 2.5 x upper limit of normal
- •9. 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
- •10. Patients willing and able to comply with the protocol for the duration of the study
- •11. 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
- •12. Agree not to share study drug with another person and to return all unused study drug to the investigator or pharmacist
- •13. Male or female
- •14. Upper age limit 70 years
- •15. Lower age limit 18 years
- •Updated 10/07/2017: upper age limit changed from 65 to 70 years.
排除标准
- •1. Patients with allergies or contraindications to receiving Fludarabine, Lenalidomide, ciclosporin or ATG
- •2. Pregnant or lactating women
- •3. Adults of reproductive potential not willing to comply with the Lenalidomide Risk Minimisation Plan
- •4. Patients with organ allografts
- •5. Any co-morbidity that, in the investigators opinion, would affect the patient?s participation in this study
- •6. Patient who have taken any other investigational medical product within 4 weeks of starting conditioning therapy
- •Added 10/07/2017:
- •7. Patients with known positive serology for HIV/Hepatitis B/Hepatitis C
- •8. Patients who have undergone a previous allogeneic stem cell transplant
- •9. Patients who have previously progressed on Lenalidomide
研究者
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