NCT04288765撤回3 期
Carfilzomib, Daratumumab, Lenalidomide and Dexamethasone as First Line Treatment in Multiple Myeloma
Grupo Cooperativo de Hemopatías Malignas1 个研究点 分布在 1 个国家开始时间: 2020年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Complete response with negative minimal residual disease
研究概览
简要总结
Carfilzomib in combination with lenalidomide, daratumumab and dexamethasone (KRDd) can induce profound clinical responses. The investigators want to observe the effectiveness of the quadruple therapy of carfilzomib, lenalidomide, daratumumab and dexamethasone on patients receiving 8 cycles of KRDd with autologous stem cell transplantation versus patients with 8 cycles of KRDd without autologous stem cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed and previously untreated multiple myeloma by the International Myeloma Working Group criteria that requires treatment based on: Presence of elevated calcium, renal failure, anemia and/or bone lesions (CRAB) Clonal bone marrow plasma cells ³ 60% Involved/uninvolved serum free light chain ratio ³ 100 >1 focal lesions on MRI studies (³5 mm in size)
- •Age > 18 years
- •Functional stage of 0 - 1 measured by the Eastern Cooperative Oncology Group (ECOG) scale.
- •Capacity and willingness to provide a written informed consent.
排除标准
- •POEMS syndrome
- •Systemic amyloidosis
- •Plasma cells leukemia
- •Radiotherapy on multiple sites on the period of 4 weeks before the initiation of treatment (1 week if it is one region)
- •Improper liver function: total bilirubin > 1.5 x upper limit of normal (ULN) or > 3 x ULN in patients with Gilbert syndrome, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 3.0 x ULN.
- •Non-controlled systematic active infection (viral, bacterial and/or fungic).
- •Patients with known infection by human immunodeficiency virus (HIV).
- •Active infection by hepatitis B.
- •Active infection by hepatitis C.
- •Significant cardiovascular diseases as uncontrolled or symptomatic arrhythmias, congestive heart failure or acute myocardial infarction within 2 months prior to screening, or any New York Heart Association (NYHA) class 3 or 4 heart disease.
- •Diagnosis of previous malignancies for 2 years, with exception of patients with basal or squamous cell carcinoma or "in situ" carcinoma of cervix or breast.
- •History of allergic reaction or severe anaphylaxis to humanized or murine monoclonal antibodies.
- •Pregnant or lactating women.
研究组 & 干预措施
Group A - Non transplant
Experimental
Carfilzomib Lenalidomide Daratumumab Dexamethasone
干预措施: Daratumumab Only Product in Parenteral Dose Form (Drug)
Group B - transplant
Active Comparator
Carfilzomib Lenalidomide Daratumumab Dexamethasone Autologous stem cell transplantation (ASCT)
干预措施: Daratumumab Only Product in Parenteral Dose Form (Drug)
结局指标
主要结局
Complete response with negative minimal residual disease
时间窗: 10 months
Complete response with MRD-negative disease measured by inmunophenotype with the International Myeloma Working Group response criteria
次要结局
- Rate of Adverse Events(36 months)
- Overall survival(36 months)
- Progression free survival(36 months)
研究者
研究点 (1)
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