An Open-Label, Multi-Center Phase 2 Trial of Denosumab in the Treatment of Relapsed or Plateau-Phase Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 96
- 主要终点
- Complete Response or Partial Response Based on M-Protein Assessments Only
研究概览
简要总结
The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.
详细描述
Patients who have relapsed myeloma have failed treatment regimens and have had disease progression following their last treatment regimen. Despite newer salvage therapies, their treatment options are limited and may include best supportive care and investigational therapy. Patients with plateau-phase myeloma have a stabilized serum M-protein level without further tumor regression despite continued treatment. Recent evidence suggests that their prognosis might improve with further reduction in serum M-protein or prolongation of time to disease progression (TTP). These patients are candidates for investigational agents that could further reduce tumor burden or increase TTP.
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
- •age ≥ 18 years
- •clinical diagnosis of relapsed or plateau-phase multiple myeloma
- •measurable disease (>0.5 g/dL) as determined by special blood tests
- •ECOG 0 or 1
排除标准
- •newly diagnosed myeloma
- •non-secretory myeloma
- •plasma cell leukemia or plasma cell dyscrasia with POEMS syndrome
- •prior allogeneic stem cell transplant
- •administration of oral or IV bisphosphonates within 2 weeks of enrollment to study
- •Other criteria also apply.
研究组 & 干预措施
Denosumab
干预措施: DENOSUMAB (Drug)
结局指标
主要结局
Complete Response or Partial Response Based on M-Protein Assessments Only
时间窗: Up to 18 months
Complete response or partial response based on serum M-Protein assessments. Complete response is defined as absence of original M-protein in serum by immunofixation, and partial response is defined as ≥ 50% reduction from baseline in serum M-protein, both maintained for a minimum of 6 weeks.
次要结局
- Complete Response Based on M-Protein Assessments Only(Up to 18 months)
- Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only(Up to 18 months)