跳至主要内容
临床试验/NCT03638232
NCT03638232已完成不适用

Myeloma Treatment in Real Life : Pharmacoepidemiological Approach in Midi-pyrénées

University Hospital, Toulouse0 个研究点目标入组 236 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
236
主要终点
Evaluation of myeloma treatment observance in real life as assessed by data collected in french national system of information of health insurance

研究概览

简要总结

As part of an oral treatment regimen in ambulatory practice, certain uses in connection with drug consumption associated could alter treatment outcomes observed in randomized clinical trials.

The increase in progression-free survival in myeloma may be accompanied by an impaired quality of life and a resurgence of pain symptoms over time, which could potentially lead to medication overuse involving painkillers but also psychotropic drugs. These combined consumption may affect survival through mechanisms of pharmacological or non-pharmacological interactions.

As part of this project, we wish to explore the scheme of adherence to myeloma drugs, and thus validate the decision diagram of hypothesis of not adequate of drug use in ambulatory conditions, from observational data. This discrepancy could result from poor adherence or suboptimal drug use but also from concomitant exposures to other drugs which may interact with myeloma. Before considering a study of greater magnitude that could address the consequences of non optimal drug use on clinical response criteria, such as duration of response or survival, it seems appropriate to confirm these assumptions within ' an exploratory study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Beneficiaries or entitled to health insurance or covered by the national system of information of health insurance
  • Identified as multiple myeloma
  • Incident patient : Subject presenting none of inclusion criteria during the 6 months observation period

排除标准

  • Non incident patient : Subject presenting at least one of inclusion criteria during the 6 months observation period

结局指标

主要结局

Evaluation of myeloma treatment observance in real life as assessed by data collected in french national system of information of health insurance

时间窗: Through the end of study (15 months)

次要结局

  • Evaluation of respect of official recommendation related to observance in multiple myeloma treatment as assessed by expression of Medication Possession Ratio (MPR)(Through the end of study (15 months))
  • Description of care consumption in multiple myeloma as assessed by data collected in french national system of information of health insurance(Through the end of study (15 months))
  • Description deliverance scheme of treatment used in multiple myeloma as assessed by data collected in french national system of information of health insurance(Through the end of study (15 months))

研究者

申办方类型
Other
责任方
Sponsor

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