NCT05184595

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Carfilzomib delivered in OH only	Patients receive the whole treatment en OH.
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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-03-01
• Completion: 2024-10-30
• First posted: 2022-01-11
• Last updated: 2022-01-11