Clinical trial NCT05184595: Cost-Utility Analysis of Home-based Versus Hospital-based Chemotherapy in Multiple Myeloma: Case of Carfilzomib
Official title: Cost-Utility Analysis of Home-based Versus Hospital-based Chemotherapy in Multiple Myeloma: Case of Carfilzomib
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Carfilzomib
Hospital-at-Home (HaH)
Outpatient-Hospital (OH)
Cost-Utility
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incremental cost-utility ratio (ICUR) expressed in euros per QALY.
timeFrame: Up to 20 months
measure: Differences of quality of life in cancer patients between each group
timeFrame: Up to 20 months
measure: Differences of quality of life in myeloma patients between each group
timeFrame: Up to 20 months
measure: Cost of care
timeFrame: Up to 20 month
Secondary outcomes:
measure: Healthcare resource utilization
timeFrame: Up to 20 months
measure: Adverse events related to myeloma treatment
timeFrame: Up to 20 months
measure: Patients and caregivers' satisfaction
timeFrame: Up to 20 months
Other outcomes:
Locations:
Study officials:
affiliation: Central Hospital, Nancy, France
name: Pierre FEUGIER
role: PRINCIPAL_INVESTIGATOR
References: