A Phase I Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of dasatinib with bortezomib in the treatment of relapsed or refractory multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of multiple myeloma with measurable disease
- •Evidence of relapsed or refractory disease and at least 2 prior therapies for multiple myeloma
- •Eastern Cooperative Oncology Group Performance Status of 0 - 2
- •Last treatment for multiple myeloma not within 21 days prior to study treatment initiation
- •Bone marrow transplant not within 3 months prior to study treatment initiation
- •Required baseline hematology and chemistry parameters.
排除标准
- •Clinically significant cardiac disease (New York Heart Association Class III or IV)
- •Abnormal QT interval corrected for heart rate using Fridericia's formula prolonged (>450 msec) after electrolytes have been corrected on baseline electrocardiogram
- •Malabsorption syndrome or uncontrolled gastrointestinal toxicities
- •Dementia, chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
- •Clinically significant pleural effusion in the previous 12 months or current ascites
- •Clinically significant coagulation or platelet function disorder
- •Intolerance to dasatinib and/or bortezomib
- •Acute diffuse infiltrative pulmonary disease
- •Prior or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer currently in complete remission, cervical carcinoma in situ, or any other cancer from which the participant has been disease-free for 3 years.
研究组 & 干预措施
Dasatinib + Bortezomib + Dexamethasone
Phase I dose escalation study
干预措施: Dasatinib (Drug)
Dasatinib + Bortezomib + Dexamethasone
Phase I dose escalation study
干预措施: Bortezomib (Drug)
Dasatinib + Bortezomib + Dexamethasone
Phase I dose escalation study
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone
时间窗: Days 1 to 21
MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity in at least 2 out of 6 or fewer participants in that cohort. If MTD is not reached, the recommended MTD is the maximum dose that the participants received.
MTD and Recommended MTD of Bortezomib in Combination With Dasatinib and Dexamethasone
时间窗: Days 1 to 21
MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity in at least 2 out of 6 or fewer participants in that cohort. If MTD is not reached, the recommended dose is the maximum dose that the participants received.
次要结局
- Best Overall Tumor Response Rate (RR) As Assessed Using International Uniform Response Criteria for Multiple Myeloma and Criteria of the European Bone Marrow Transplant Registry(Day 1 until last tumor assessment (maximum reached: 9 months))
- Duration of Response(First occurrence of response to disease progression or death, whichever occurred first (maximum reached: 12.2 months))
- Progression-free Survival(Day 1 to disease progression or death, whichever came first (maximum reached: 14 months))
- Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, AEs, and Drug-related AEs by Grade(Continuously from Day 1 until last day of study medication + 30 days (maximum reached: 10 months))