Phase I/II Study of Sorafenib, Lenalidomide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Number of Participants With a Grade 3 and 4 Adverse Event (Phase I)
研究概览
简要总结
RATIONALE: Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sorafenib and lenalidomide may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving sorafenib together with lenalidomide and dexamethasone may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of sorafenib when given together with lenalidomide and dexamethasone and to see how well they work in treating patients with relapsed or refractory multiple myeloma.
详细描述
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of sorafenib tosylate and lenalidomide in combination with dexamethasone in patients with relapsed or refractory multiple myeloma. (phase I)
- To describe the toxicity of this regimen in these patients. (phase I)
- To evaluate the confirmed response in patients treated with this regimen. (phase II)
Secondary
- To correlate clinical effects (adverse events and/or tumor response or activity) with pharmacologic parameters (pharmacokinetics or pharmacodynamics) and/or biologic results (correlative laboratory). (phase II)
- To assess overall survival and time to disease progression in patients treated with this regimen. (phase II)
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sorafenib + Lenalidomide + Dexamethasone
干预措施: dexamethasone (Drug)
Sorafenib + Lenalidomide + Dexamethasone
干预措施: sorafenib tosylate (Drug)
Sorafenib + Lenalidomide + Dexamethasone
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Number of Participants With a Grade 3 and 4 Adverse Event (Phase I)
时间窗: up to 3 years
Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. Description of Grades: Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death
Number of Participants Who Achieve a Confirmed Response (Partial Response [PR], Very Good PR [VGPR], Complete Response [CR], or Stringent CR [sCR]) (Phase II)
时间窗: Duration on Treatment (up to 3 years)
Response that was confirmed on 2 consecutive evaluations during treatment * CR: Complete disappearance of M-protein from serum \& urine on immunofixation, \<5% plasma cells in bone marrow (BM) * sCR: CR plus normal FLC ratio \& absence of clonal cells in BM * VGPR: \>=90% reduction in serum M-component; Urine M-Component \<100 mg per 24 hours; \<=5% plasma cells in BM * PR: \>= 50% reduction in serum M-Component and/or Urine M-Component \>= 90% reduction or \<200 mg per 24 hours; or \>= 50% decrease in difference between involved and uninvolved FLC levels
次要结局
- Time to Disease Progression (Phase II)(From registration to progression (up to 3 years))
- Changes in Microvessel Density From Baseline to Post-treatment and Correlation With > Clinical Outcomes (Phase II)(Pre and Post treatment (up to 3 years))
- Change in Apoptosis Rate From Baseline to Post-treatment and Correlation With > Clinical Outcomes (Phase II)(Pre and Post treatment (up to 3 years))
- Plasma Cell Gene Expression Profiles and Correlation With > Clinical Outcomes(Post treatment)
- Percentage of Stained Circulating Endothelial Cells and Endothelial Progenitor Cells and Correlation With Clinical Outcomes (Phase II(Post treatment)
- Change in VEGF Expression Levels and Correlation With Clinical Outcomes (Phase II)(Post treatment)
- Overall Survival (Phase II)(From registration to death (up to 3 years))