Cost-Utility Analysis of Home-based Versus Hospital-based Chemotherapy in Multiple Myeloma: Case of Carfilzomib (ADHOMY2)
Carfilzomib is administered in treatment of Multiple Myeloma intravenously on two consecutive days, each week for three weeks (days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (days 17 to 28). With COVID pandemic, the investigators had to limit patient visits to the hospital. The treatment protocols were modified by switching to weekly injections of carfilzomib according to the PLEIADES and ARROW 2 studies.
Considering the frequency of intravenous (IV) administration, home-based chemotherapy in Hospital-at-Home (HaH) setting is an attractive and suitable alternative to standard hospital-based chemotherapy in Outpatient-Hospital (OH), and is expected to provide both cost-savings for the Health Insurance (HI) and improvement in patient quality of life (QoL).
The purpose of the study is to assess the cost-utility of home-based compared to hospital-based carfilzomib administration in multiple myeloma.
The investigators are also planning on assessing healthcare resource utilization and related costs, adverse and intercurrent events, and patients' quality of life and satisfaction, for each strategy.
研究概览
地位
条件
详细说明
All participants receive the first cycle of treatment in OH. They are then randomized between exclusive OH treatment and combined treatment in OH and at home with HaH services.
For the HaH group, the first injection of each cycle is delivered in OH. The rest of the cycle is delivered at home by HaH after a clinical examination (by nurse or general practitionner).
Primary and secondary endpoints are collected at day 1 of cycle 3, 6, 9, 12, 18 and one month after the end of treatment.
Participants we leave the protocol prematurely in case of treatment failure, toxicity or if participant ask to. For those patients, the end of study visit will be done one month after ending treatment.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：ANDREIA CARVALHO DE FREITAS
- 电话号码：0383859305
- 邮箱：a.carvalhodefreitas@chru-nancy.fr
研究联系人备份
- 姓名：Pierre FEUGIER
- 电话号码：0383853283
- 邮箱：p.feugier@chru-nancy.fr
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age > 18 years
- relapsed multiple myeloma, at least one prior line of treatment
- treatment with carfilzomib validated in a multidisciplinary consultation meeting and accepted by the patient
- The patient accepts mixed management and benefits from the support of his/her family and friends (see ANAES 2003 criteria). If the patient does not have a caregiver, he/she can still participate in the research and the absence of a caregiver will be collected.
- Patient capable of adhering to care (cf. ANAES 2003 criteria)
- Patient affiliated to a social security system or beneficiary of such a system.
- Patient having received full information on the organization of the research and having signed his or her informed consent
Exclusion Criteria:
- Person with a contraindication to carfilzomib
- Women of childbearing age who do not have effective contraception
- Persons referred to in articles L. 1121-5, L. 1121-7; L1121-8 and L1122-1-2 of the Public Health Code
- Pregnant woman, parturient or nursing mother
- Minor (not emancipated)
- Adult person under a legal protection measure (guardianship, curatorship, safeguard of justice)
- A person of full age who is unable to express his or her consent
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Carfilzomib delivered in OH only
Patients receive the whole treatment in OH. Primary and secondary endpoints are collected at day 1 of cycle 3, 6, 9, 12, 18 and one month after. Patients leave the protocol prematurely due to treatment failure, toxicity or patient wishes. For those patients, the end of study visit will be done one month after ending treatment. |
Patients receive the whole treatment en OH.
|
|
实验性的：Carfilzomib delivered in OH and HaH combined
Patients receive the first cycle of treatment in OH. Then, they are randomized between exclusive OH treatment and combined treatment in OH and at home with HaH services. For the HaH patients group, the first injection of each cycle is delivered in OH. The rest of the cycle is delivered at home by HaH after a clinical examination (by nurse or general practitionner). Primary and secondary endpoints are collected at day 1 of cycle 3, 6, 9, 12, 18 and one month after. Patients leave the protocol prematurely due to treatment failure, toxicity or patient wishes. For those patients, the end of study visit will be done one month after ending treatment. |
Patients receive the first cycle of treatment in OH.
Then, they are randomized between exclusive OH treatment and combined treatment in OH and at home with HaH services.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incremental cost-utility ratio (ICUR) expressed in euros per QALY.
大体时间：Up to 20 months
|
Incremental cost-utility ratio (ICUR) of home-based compared to hospital-based carfilzomib administration in multiple myeloma, expressed in euros per QALY according to EQ-5D-5L questionnaire (EuroQOL 5 dimensions 5 levels) from 0 to 1 (1 being the best state with no problem)
|
Up to 20 months
|
|
Differences of quality of life in cancer patients between each group
大体时间：Up to 20 months
|
Difference of quality of life according to EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire with 30 questions, answer from 1 to 4, 1 being the best state with no problem)
|
Up to 20 months
|
|
Differences of quality of life in myeloma patients between each group
大体时间：Up to 20 months
|
Difference of quality of life according to EORTC QLQ-MY20 questionnaire (European Organisation for Research and Treatment of Cancer Quality of life Questionnaire with 20 questions related to myeloma symptoms, answer from 1 to 4, 1 being the best state with no problem)
|
Up to 20 months
|
|
Cost of care
大体时间：Up to 20 month
|
Cost for Health Insurance by patients, at the end of treament: Total costs per patient and average cost per injection
|
Up to 20 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Healthcare resource utilization
大体时间：Up to 20 months
|
|
Up to 20 months
|
|
Adverse events related to myeloma treatment
大体时间：Up to 20 months
|
|
Up to 20 months
|
|
Patients and caregivers' satisfaction
大体时间：Up to 20 months
|
- Patients' and Caregivers' Satisfaction Scores at the end of the treatment according to questionnaires with (opened and closes-questions) : 4 questions for OH group 9 questions for OH and HaH group 7 questions for caregiver
|
Up to 20 months
|
合作者和调查者
调查人员
- 首席研究员：Pierre FEUGIER、Central Hospital, Nancy, France
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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