ISRCTN23172547已完成不适用
A randomised phase III study of intravenous (i.v.) zoledronate (administered for 12 versus 36 months) as an adjunct to standard therapies in the treatment of multiple myeloma
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)0 个研究点目标入组 407 人开始时间: 2005年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 407
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon and Durie criteria
- •2. Patients with at least one osteolytic bone lesion on conventional radiographs (plain film)
- •3. Inclusion in HOVON 49 or HOVON 50 trial
- •4. Inclusion in HOVON 57 at the same time as inclusion in HOVON 49 or HOVON 50
- •5. Date of inclusion in HOVON 57 trial before date start chemotherapy HOVON 49 or HOVON 50
- •6. Aged greater than or equal to 18 years
- •7. World Health Organization (WHO) performance status 0 - 3
- •8. Negative pregnancy test at inclusion if applicable
- •9. Written informed consent
排除标准
- •1. Treatment with bisphosphonates at any time during the 12 months prior to registration. Exception: patients may have received up to three doses of a bisphosphonate for hypercalcaemia provided this has been administered greater than 14 days prior to registration
- •2. Corrected (adjusted for serum albumin) serum calcium less than 200 mmol/l or greater than 280 mmol/l
- •3. Serum creatinine greater than 265 micromol/l
- •4. Total bilirubin greater than 30 micromol/l
- •5. Patients unwilling or unable to comply with protocol
- •6. Severe cardiac dysfunction (New York Heart Association [NYHA] classification III - IV)
- •7. Patients with clinically significant hypersensitivity to zoledronic acid or other bisphosphonates
- •8. Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women)
- •9. Lactating patients if applicable
研究者
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