EUCTR2012-005804-16-FR进行中（未招募）1 期
Front-line therapy with Carfilzomib, Lenalidomide, and Dexamethasone (CRd) induction followed by autologous stem cell transplantation, CRd consolidation and Lenalidomide maintenance in Newly Diagnosed Multiple Myeloma Patients =65 years old : a phase II study of the Intergroupe Francophone du Myélome (IFM) - IFM CRd
CHU de Toulouse0 个研究点目标入组 46 人开始时间: 2013年4月22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
- 46
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
入选标准
- •-Age = 18 years and = 65 years at the time of signing informed consent form
- •-Patients diagnosed with multiple myeloma based on the new International Myeloma Working Group Diagnostic Criteria for plasma cells disorders (Leukemia 2009)
- •-Subjects must have symptomatic myeloma with CRAB criteria
- •-Subjects must have measurable disease requiring systemic therapy defined by serum M-component = 5g/l, urine M-component = 200 mg/24h or serum FLC = 100 mg/l.
- •-Subjects must not have been treated previously with any systemic therapy for multiple myeloma. Prior treatment with corticosteroids or radiation therapy does not disqualify the subject
- •-Life expectancy = 3 months
- •-ECOG performance status 0–2
- •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 46
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 46
排除标准
- •-Pregnant or lactating females
- •-Evidence of mucosal or internal bleeding and/or platelet refractory
- •-Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to enrollment
- •-Known human immunodeficiency virus infection
- •-Active hepatitis viral infection and history of hepatitis B or C
- •-Prior myeloma systemic therapy
- •-Treatment by localized radiotherapy if the interval between the end of radiotherapy and initiation of protocol therapy lower than 2 weeks.
- •-Treatment by corticosteroids if exceed the equivalent of 160 mg of dexamethasone in a 2-week period before initiation therapy.
- •-Subjects not eligible for high dose therapy
研究者
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