Comparison of Different Geriatric Screening Methods in Newly Diagnosed Multiple Myeloma Patients, and Assessment of Therapeutic Efficacy and Toxicity in Fit and Frail Patients. A Multicenter Observational Belgian Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 20
- 主要终点
- Comparison of the geriatric categorization (fit versus frail) by standard clinical assessment versus by geriatric scoring.
研究概览
简要总结
The purpose of this study is to compare clinical judgment and comprehensive geriatric assessment as screening tools for optimization of treatment for newly diagnosed elderly multiple myeloma patients.
详细描述
Given the growing elderly multiple myeloma population, the increase in therapeutic possibilities and the importance of geriatric screening, this study wants:
- to compare clinical judgment with standardized geriatric screening approaches (G8, CGA and IMWG score) in newly diagnosed elderly myeloma patients and to evaluate their influence on the detection of geriatric problems and on the choice of the anti-myeloma treatment
- to evaluate how geriatric scoring and the subsequent treatment choice influences the therapeutic efficacy and toxicities
Geriatric scoring will be performed in 3 different ways:
- by clinical judgment performed by the treating physician
- by validated scoring systems independently performed by a trained nurse/ health care worker. Initial scoring will be done by the G8 score. If an abnormal G8 score is present (<= 14), CGA will be performed.
- based on the CGA parameters, the Palumbo/IMWG geriatric score will be calculated
Results obtained by physician-based assessment and by geriatric assessment will be compared before treatment initiation. If, and to what extent the knowledge of the GA influences the therapeutic decision of the treating physician will be registered. In addition, we will register which geriatric problems diagnosed by the CGA assessment were already known or unknown by the treating physician. After three months of treatment and at the time of disease progression, geriatric assessment will be repeated in order to judge the evolution (disappearance, improvement, worsening) of the scored parameters, or the emergence of new geriatric symptoms.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed multiple myeloma
- •age => 70 years
- •no previous anti-myeloma treatment except for local radiotherapy or short course (max 4 days) of high-dose dexamethasone
- •signed informed consent
- •patients included in an interventional therapeutic trial are eligible
排除标准
- •previous systemic anti-myeloma treatment
- •severe mental or cognitive disorder precluding geriatric assessment
- •patient refusal to sign informed consent
结局指标
主要结局
Comparison of the geriatric categorization (fit versus frail) by standard clinical assessment versus by geriatric scoring.
时间窗: At baseline
Comparison of geriatric categorization by standard clinical assessment (fit versus frail ) versus by geriatric scoring ( G8 score, CGA (Comprehensive Geriatric Assessment) and IMWG score will result in fit or frail) will be presented in proportion of agreement (accuracy, specificity, sensitivity, positive predictive value, negative predictive value).
次要结局
- Treatment discontinuation(Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.)
- Change in geriatric categorization (fit versus frail) by CGA from baseline to time of first relapse of multiple myeloma(At first relapse of multiple myeloma, defined according to IMWG criteria (ref. Durie et al. Leukemia 2006))
- Description of the causes for dose-reduction and/or treatment discontinuation(Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.)
- Overall survival(Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.)
- Comparison of the geriatric categorization (fit versus frail) by CGA versus by IMWG scoring(At baseline)
- Change in geriatric categorization (fit versus frail) by CGA from baseline to 3 months of anti-myeloma therapy.(after 3 months of anti-myeloma treatment)
- Description of geriatric problems detected by CGA ( unknown items assessed by validated CGA scoring tool)(ref. Kenis et al. An of Onc 2013;24:1306)(At baseline)
- Response rate(Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.)
- Progression free survival(Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.)
- Treatment-related deaths(Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.)
- Grade 3 and 4 non-hematological and grade 4 hematological adverse events (according to CTCAE 4.0)(Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.)
- Dose reductions of anti-myeloma treatment(Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.)