Cost-Utility Analysis of Home-based Versus Hospital-based Chemotherapy in Multiple Myeloma: Case of Carfilzomib

NCT ID: NCT05184595

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-10-30

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Carfilzomib delivered in OH only

Intervention Type: OTHER

Patients receive the whole treatment en OH.

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.

Group Type: EXPERIMENTAL

Carfilzomib delivered in OH and HaH combined

Intervention Type: OTHER

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.

Interventions

Carfilzomib delivered in OH only

Patients receive the whole treatment en OH.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Pierre FEUGIER

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pierre FEUGIER

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Central Contacts

Andreia CARVALHO DE FREITAS

Role: CONTACT

a.carvalhodefreitas@chru-nancy.fr

0383859305

Pierre FEUGIER

Role: CONTACT

p.feugier@chru-nancy.fr

0383853283

Other Identifiers

2020-A00605-34

Identifier Type: -

Identifier Source: org_study_id