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临床试验/NCT00733538
NCT00733538已完成4 期

Stage I Multiple Myeloma Treatment

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2004年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
89
试验地点
1
主要终点
Survival without progress

研究概览

简要总结

  • Assessment of survival without progression of stage I MM in two groups: arm A: simple survey and arm B: administration of Zoledronate.
  • Describe different progression's type noticed and define the prognosis factors of a fast evolution.

详细描述

RATIONAL:

Multiple Myeloma in spite of therapy progresses mainly due to stem cell auto transplant, still remain a deadly disease. About 2000 new cases are diagnosed every year in France. The asymptomatic Stage I MM according to Duries and Salmon's staging are usually only watch over and only treated at progression. Zoledronate is a third generation aminobiphosphonate (BP), probably the most powerful among the available compounds which received market clearance authorisation in MM with bone damage. During MM, bone's hyper resorption is premature. Interactions exist between tumor growth and bone lyses. Zoledronate's got a proper antimyeloma's action (induce plasma cells apoptosis). We propose to test the early use of Zoledronate as soon as stage I MM to delay progression.

STUDY'S OBJECTIVES:

  • PRINCIPAL: Assessment of survival without progression stage I MM in two groups: A arm: simple survey and B arm: administration of BP.
  • SECONDARY: Describe different progression's type noticed (bone/extra bone) and define the prognosis factor of a fast stage I MM evolution (standard factors, cytogenetic 13 deletion, bone's restructuring strains: crosslaps, bone alkaline phosphatase), list side effects.

STUDY'S KIND:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
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

入选标准

  • stage I multiple myeloma without bones injuries

排除标准

  • abnormal kidney function
  • VIH infection
  • Hepatic incapacity
  • pregnancy
  • Associate pathology

研究组 & 干预措施

1

Active Comparator

patients receiving zometa treatment

干预措施: zometa (Drug)

结局指标

主要结局

Survival without progress

时间窗: every month during 6 years

次要结局

  • predictive factors of a fast evolution of multiple myeloma(every month during 6 years)
  • Secondary effects of zolédronate(every month during six years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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