A Phase II Trial of Revlimid® and "On Demand" Dexamethasone Dosing in Patients With Newly Diagnosed Symptomatic Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS) Rate at 12 Months
研究概览
简要总结
RATIONALE: Lenalidomide and dexamethasone may stop the growth of multiple myeloma by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well lenalidomide works with or without dexamethasone in treating patients with newly diagnosed multiple myeloma.
详细描述
OBJECTIVES:
Primary
- To assess the progression-free survival at 1 year in patients with newly diagnosed symptomatic multiple myeloma treated with lenalidomide alone or in combination with dexamethasone added for disease progression or lack or partial response.
Secondary
- To assess the response rate of this regimen in these patients.
- To assess the toxicity of this regimen in these patients.
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
Lenalidomide with On-Demand Dexamethasone
Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles.
Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression.
干预措施: dexamethasone (Drug)
Lenalidomide with On-Demand Dexamethasone
Lenalidmoide: 25mg once daily orally with food on days 1-21 of 28 day cycle until progression or to a maximum of 18 cycles.
Dexamethasone: 10-40 mg once weekly (days 1, 8, 15, & 22) orally with food until progression.
干预措施: lenalidomide (Drug)
结局指标
主要结局
Progression-free Survival (PFS) Rate at 12 Months
时间窗: 12 months from registration
PFS rate at 12 months is defined as the percentage of participants who are alive and progression-free at 12 months. Progression is exclusively defined as a patient with progressive disease while receiving treatment with lenalidomide in combination with dexamethasone. Progression was defined as any one or more of the following: An increase of 25% from lowest confirmed response in: * Serum M-component (absolute increase \>= 0.5g/dl) * Urine M-component (absolute increase \>= 200mg/24hour * Difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl * Bone marrow plasma cell percentage (absolute increase of \>=10%)
次要结局
- Confirmed Response Rate(Up to 18 cycles from registration)
- Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event at Least Possibly Related to Treatment (Toxicity)(Duration on treatment (up to 18 cycles from registration))
- Overall Survival (OS)(Time from registration to death (up to 3 years))
- Progression-free Survival (PFS)(Time from registration to progression or death (up to 3 years))