Results of Phase III Study to Assess if Zoledronic Acid Have Antumor Activity in Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- progression-free disease and overall toxicity in myeloma multiple
研究概览
简要总结
Assess the impact in outcome of the use of zoledronic acid in multiple myeloma.
详细描述
Assess if the use of zoledronic acid can improve outcome in patients with multiple myeloma whose are treated with cytoreductive therapy and stem cell transplant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of multiple myeloma No previous treatment Symptomatic High risk (ISS) or stage III ( Durie-Salmon) No severe comorbidities -
排除标准
- •Pregnancy HIV + Refuse treatment
研究组 & 干预措施
zoledronic acid or not zoledronic acid
patients with multiple myeloma will be treated with cytoreductive therapy following by stem cell transplant and did not received zoledronic acid
干预措施: zoledronic acid (Drug)
zoledronic acid
Patients with multiple treated with cytoreductive therapy following by stem cell transplant will be planned to received zoledronic acid
干预措施: zoledronic acid (Drug)
结局指标
主要结局
progression-free disease and overall toxicity in myeloma multiple
时间窗: 3 years
In patients treated with cytoreductive therapy following by stem cell transplant and that received zoledronic acid by 2 years,they were evaluable for assess antitumor effect of zoledronic acid
次要结局
- skeletal event(3 years)