An Open-Label, Pilot Study of Samarium - Sm 153 Lexidronam (Quadramet) in Patients With Relapsed or Refractory Multiple Myeloma and Bone Pain
试验速览
- 阶段
- 1 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
- Confirmed clinical response of serum and urine monoclonal protein (Phase II)
研究概览
简要总结
RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to cancer cells and not harm normal cells. Zoledronic acid and pamidronate may help relieve bone pain caused by multiple myeloma. Giving samarium Sm 153 lexidronam pentasodium together with zoledronic acid or pamidronate may be an effective treatment for multiple myeloma.
PURPOSE: This phase I/II trial is studying the side effects and best dose of samarium Sm 153 lexidronam pentasodium when given together with zoledronic acid or pamidronate and to see how well it works in treating patients with relapsed or refractory multiple myeloma and bone pain.
详细描述
OBJECTIVES:
Primary
- Determine the safety and tolerability of samarium Sm 153 lexidronam pentasodium in combination with zoledronic acid or pamidronate disodium in patients with relapsed or refractory multiple myeloma and bone pain. (Phase I)
- Determine the clinical response in patients treated with these regimens. (Phase II)
Secondary
- Determine the effect of these regimens on changes in patient-reported bone pain levels.
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
Sm 153 lexidronam
干预措施: Zoledronic acid (Drug)
Sm 153 lexidronam
干预措施: Pamidronate (Drug)
Sm 153 lexidronam
干预措施: Sm 153 lexidronam (Radiation)
结局指标
主要结局
Confirmed clinical response of serum and urine monoclonal protein (Phase II)
时间窗: 12 weeks
Toxicity (Phase I)
时间窗: 12 weeks
次要结局
- Response (Phase I)(12 weeks)
- Bone pain response (Phase II)(12 weeks)
- Toxicity (Phase II)(12 weeks)