NCT00242528撤回4 期
Open-label Study, to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Bone Lesions Secondary to Multiple Myeloma.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Novartis
研究概览
简要总结
To evaluate the safety and tolerability of intravenous zoledronic acid in the treatment of patients with multiple myeloma stage III with bone lesions related to Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 -
- •Confirmed Diagnosis of Durie-Salmon Stage III Multiple Myeloma, with the following clinical characteristics:
- •A. At least 1 osteolytic bone lesion demonstrable in a conventional X-ray film. B. The patient will have to be receiving treatment for primary neoplasia, at the time of the start of this trial.
- •- Ambulatory patients aged ≥ 18 years.
排除标准
- •Treatment with bisphosphonates in any moment during the last 12 months before visit
- •except for those patients that received only one dosis of bisphosphonates for any indication and when the administration has been 14 days before or older.
- •Patients with an absence of a bone lesion clearly related to the primary cancer, and that is detectable in a conventional bone X-ray (simple film).
- •Patients with a Serum Calcium level of ≤ 8 g/dl (2.00 mmol/L) or ≥ 12 mg/dL (3.00 mmol/L)
- •Treatment with other investigational drugs within 30 days before inclusion in the trial.
- •Serum Creatinine levels of > 3 mg/dl (265 umol/L).
- •Total Billirubin levels of > 2.5 mg/dl (43 umol/L)
- •Patients with a heart condition that has the NYHA criteria for a Grade III and IV functional class
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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