ACTRN12606000433505尚未招募1 期
A Three-Stage Phase I/II Dose-Escalation Study of High-Dose Melphalan with Palifermin for Patients with Multiple Myeloma to Determine a New Maximum Tolerated Dose (MTD) of Melphalan for use in Autografting
Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 70 人开始时间: 2006年10月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Diagnosis of multiple myeloma.-No more than 12 months total prior standard-dose chemotherapy.-No previous high-dose chemotherapy or autologous transplantation procedure.-Normal liver function->2.0 x 106 CD34+ cells/kg bodyweight available for reinfusion.-ECOG performance status <3-Have achieved less than Complete Response with a recognised induction protocol-No contraindication to the use of any of the study drugs, including knownsensitivity to E coli-derived preparations.-Written informed consent.
排除标准
- •Patients with monoclonal gammopathy of undetermined significance-Patients whose general condition makes them unsuitable for intensivetreatment-Active infections or other illnesses that precludes chemotherapyadministration or patient compliance.-Serum creatinine >0.18mMol/L.-Pregnant or lactating women.
研究者
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