Magnolia Study Prolonged Protection From Bone Disease in Multiple Myeloma. An Open Label Phase 3 Multicenter International Randomised Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- time to first skeletal related event after randomisations at year two
研究概览
简要总结
Main hypothesis: Patients who continue zoledronic acid after year 2 have longer time until progression in bone disease compared to patients who stop treatment after two years?
Secondary hypothesis: Serum will bone markers increase prior to progression in bone disease in the individual patient?
Secondary hypothesis: Low-dose CT will detect more cases of osteolytic bone disease in Multiple Myeloma compared to conventional radiography
详细描述
Newly diagnosed myeloma patients will be followed for 4 years. The first two years they will be treated with zoledronic acid monthly. At year 2 they will be randomized to A continue treatment for 2 more years or B stop treatment. The primary outcome of the study will be time to progressive bone disease from year 2 and onward.
Serum bone markers will be measured throughout the study. In patients who experience progressive bone disease, development of bone markers prior to the radiological progression will be investigated to see the if it could have been predicted with the use of serum markers
During the four year period patients will have low-dose CT superior and conventional radiography made at predefined time points. The secondary outcome of the study is to compare the sensitivity of the two modalities
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Symptomatic Multiple Myeloma regardless of bone disease status
- •Signed Informed Consent
- •Age ≥ 18 years
- •Remaining life expectancy ≥ 2 years
- •Any concurrently anti-myeloma treatment are allowed
排除标准
- •Previous treatment with bisphosphonate within the last 6 months
- •Severely reduced renal function (creatinine clearance <30 mL/min despite fluid replacement)
- •Known concurrent malignancy, excluding skin cancer
- •Known hypersensitivity to zoledronic acid
- •Pregnant or lactating women
- •Women of childbearing potential or men engaging in sexual activity with a woman of childbearing potential who refuse to use contraception
研究组 & 干预措施
zoledronic acid
treatment with zoledronic acid for 4 years
干预措施: Zoledronic acid (Drug)
no treatment
treatment with zoledronic acid withheld after two years
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
time to first skeletal related event after randomisations at year two
时间窗: From year two to year four
After two years of zoledronic acid treatment patients will be randomized to A continue treatment B stop treatment.
次要结局
- Value of serum bone marker ratio (bone resorption / bone formation markers) as predictor of skeletal related related events analysed by time-dependent multiparameter Cox regression analysis.(4 years)
研究者
Thomas Lund
MD Ph.D.
Odense University Hospital