Bone Marker-directed Dosing of ZOMETA® (Zoledronic Acid) for the Prevention of Skeletal Complications in Patients With Advanced Multiple Myeloma.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 42
- 主要终点
- Percentage of Participants With ≥1 SRE at the End of 1 Year on Study
研究概览
简要总结
This study evaluated the effectiveness and safety of a dosing method for zoledronic acid in preventing skeletal complications in multiple myeloma participants who have been on an intravenous (IV) bisphosphonate for about one to two years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Confirmed diagnosis of multiple myeloma
- •Have been on zoledronic acid or pamidronate for 1-2 years and therapy must have been initiated for osteolytic lesion, bone fracture, spinal compression, or osteopenia due to multiple myeloma
- •Stable renal function
排除标准
- •Known sensitivity to bisphosphonates
- •Receiving investigational drugs considered not safe for co-administration or have a significant effect on bone turnover
- •Current active dental problems
- •Had bone marrow transplant or blood stem cell transplant within 2 months before study entry or planned transplant within 2 months following enrollment
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Zoledronic acid
Participants received 4 milligrams (mg) or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes, every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine N-telopeptide of type 1 collagen (NTx) measurement (greater than or equal to [≥] 50 nanomoles per millimoles [nmol/mmol] creatinine or <50 nmol/mmol creatinine, respectively).
干预措施: zoledronic acid (Drug)
结局指标
主要结局
Percentage of Participants With ≥1 SRE at the End of 1 Year on Study
时间窗: 1 year
SRE was defined as pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or hypercalcemia of malignancy (HCM). SRE was assessed by centrally read radiographic bone surveys.
次要结局
- Percentage of Participants Who Experienced Spinal Cord Compression(Years 1 and 2)
- Time to First SRE on Study(Up to 2 years)
- Percentage of Participants Who Experienced Pathologic Bone Fracture(Years 1 and 2)
- Percentage of Participants Who Experienced Radiation to Bone(Years 1 and 2)
- Percentage of Participants Who Experienced HCM(Years 1 and 2)
- Time to Death(Up to 2 years)
- Percentage of Participants Who Experienced Surgery to Bone(Years 1 and 2)
- Skeletal Related Event (SRE) Rate(Years 1 and 2)
- Change From Baseline in Urinary N-telopeptide of Type 1 Collagen (uNTx)(Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 and 100/End of Study (EOS))