A Randomized Phase II Study of Bisphosphonate: Zoledronic Acid (Zometa) in the Management of Asymptomatic/Early Stage Multiple Myeloma: Hoosier Oncology Group MM02-35
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 8
- 主要终点
- · To examine the effect of intravenous zoledronic acid at the dose of 4 mg given every three months compared with observation, on percent change in bone mineral density of the spine at one year in patients with asymptomatic, smoldering and stage I MM.
研究概览
简要总结
Evidence for the beneficial effects of bisphosphonates on bone resorption in multiple myeloma has been reported extensively, showing reductions in skeletal events and improvement of several biochemical variables in bone resorption. Zoledronic acid (Zometa®, CGP42446) is the most potent clinically available bisphosphonates, with the largest therapeutic ratio between the desired inhibition of calcium resorption and the unwanted inhibition of mineralization in vitro of all the bisphosphonates.
This trial will investigate the efficacy of zoledronic acid in preventing skeletal events in patients with asymptomatic/early stage Multiple Myeloma
详细描述
OUTLINE: This is a multi-center study.
- Patients will be randomly assigned by study number to receive 4mg of zoledronic acid every three months or to be observed.
Performance status: ECOG performance status 0-3 (KPS 30 - 100)
Life expectancy: 12 months
Hematopoietic:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Diagnosis of asymptomatic multiple myeloma as defined by the criteria below:
- •Presence of bone marrow clonal plasma cells (more than 10%)
- •Presence of an M-protein in serum and/or urine (no concentration specified)
- •Serum calcium < 12 mg/dl within 14 days prior to registration. Less than 3 lytic lesions, no pathologic fractures and no osteopenia noted on skeletal survey
- •No symptoms of hyperviscosity, amyloidosis or recurrent infection
- •Bone mineral density with a T score higher than -2.0 standard deviation (not have osteoporosis) within 28 days prior to registration
- •Negative pregnancy test
排除标准
- •No previous treatment with bisphosphonates
- •No disorders of the parathyroid or thyroid glands
- •No current breastfeeding
- •No prior malignancy is allowed except for adequately treated in situ cervical cancer, Gleason < grade 7 prostate cancers
研究组 & 干预措施
A
Patients will be randomly assigned by study number to receive 4mg of zoledronic acid every three months.
干预措施: Zoledronic Acid (Drug)
结局指标
主要结局
· To examine the effect of intravenous zoledronic acid at the dose of 4 mg given every three months compared with observation, on percent change in bone mineral density of the spine at one year in patients with asymptomatic, smoldering and stage I MM.
时间窗: 18 months
次要结局
- · To examine the effect of intravenous zoledronic acid at the above schedule on percent change in bone mineral density of the total hip and femur.(18 months)