A Phase II Trial of CC-4047 Plus Dexamethasone in Patients With Relapsed of Refractory Multiple Myeloma or Amyloidosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 378
- 试验地点
- 3
- 主要终点
- The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response)
研究概览
简要总结
RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in different ways and stop cancer cells from growing. Dexamethasone and CC-4047 may stop the growth of cancer cells by blocking blood flow to the cancer. Giving CC-4047 together with dexamethasone may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving CC-4047 together with dexamethasone works in treating patients with relapsed or refractory multiple myeloma or amyloidosis.
详细描述
OBJECTIVES:
- To assess the response rate and duration of remission with low-dose CC-4047 plus dexamethasone in patients with relapsed or refractory multiple myeloma or amyloidosis.
- To assess the toxicity of CC-4047 plus dexamethasone in this patient population.
- To assess in an expansion cohort the response rate with an increase in CC-4047 dose among patients who fail to respond adequately to the initial starting dose following the first 2 courses of treatment.
- To assess the response rate and duration of remission with CC-4047 plus dexamethasone in patients with lenalidomide resistant or refractory multiple myeloma.
- To assess the response rate and duration of remission with CC-4047 plus dexamethasone in patients with previously treated light chain amyloidosis.
- To assess the response rate and duration of remission with low- and high-dose CC-4047 plus dexamethasone in patients with lenalidomide and bortezomib refractory multiple myeloma.
- To assess the response rate and duration of remission with high-dose CC-4047 plus dexamethasone in patients with relapsed or refractory myeloma who received ≤ 3 treatment regimens.
OUTLINE: Patients are grouped according to disease status (relapsed/refractory myeloma [closed to accrual as of 8/5/2008] vs lenalidomide resistant/refractory myeloma [closed to accrual as of 4/2/2009] vs previously treated light chain amyloidosis vs lenalidomide and bortezomib resistant/refractory myeloma {low-dose/day}[closed to accrual as of 11/20/09] vs lenalidomide and bortezomib resistant/refractory myeloma (high-dose/day) vs relapsed/refractory myeloma {high-dose/day}).
Patients receive oral CC-4047 on days 1-28 and oral dexamethasone on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks and then at 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
Relapsed Myeloma (<4 Prior Regimens)
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
干预措施: dexamethasone (Drug)
Relapsed Myeloma (<4 Prior Regimens)
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
干预措施: pomalidomide (Drug)
Lenalidomide Refractory Myeloma
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
干预措施: dexamethasone (Drug)
Lenalidomide Refractory Myeloma
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
干预措施: pomalidomide (Drug)
Bortezomib/Lenalidomide Refractory/Relapsed Myeloma
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
干预措施: dexamethasone (Drug)
Bortezomib/Lenalidomide Refractory/Relapsed Myeloma
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
干预措施: pomalidomide (Drug)
Bortezomib/Lenalidomide Relapsed/Refractory Myeloma
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
干预措施: dexamethasone (Drug)
Bortezomib/Lenalidomide Relapsed/Refractory Myeloma
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
干预措施: pomalidomide (Drug)
Relapsed Myeloma (< 4 Prior Regimens)
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
干预措施: dexamethasone (Drug)
Relapsed Myeloma (< 4 Prior Regimens)
Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
干预措施: pomalidomide (Drug)
Relapsed/Refractory Myeloma
Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
干预措施: dexamethasone (Drug)
Relapsed/Refractory Myeloma
Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
干预措施: pomalidomide (Drug)
Relapsed Amyloidosis
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
干预措施: dexamethasone (Drug)
Relapsed Amyloidosis
Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle
Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
干预措施: pomalidomide (Drug)
结局指标
主要结局
The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response)
时间窗: Duration of study (up to 3 years)
Response that was confirmed on 2 consecutive evaluations * Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. * Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100mg per 24hours; \<=5% plasma cells in bone marrow. * Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200mg per 24hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.
次要结局
- Progression Free Survival (PFS)(Duration of study (up to 5 years))
- Duration of Response(Duration of study (up to 5 years))