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

NCT05184595 | Unknown

• 1 other identifier: 2020-A00605-34
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Carfilzomib; Hospital-at-Home (HaH); Outpatient-Hospital (OH); Cost-Utility

Outcome Measures

Primary Outcomes (4)

• Incremental cost-utility ratio (ICUR) expressed in euros per QALY.

  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

  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

  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

  Cost for Health Insurance by patients, at the end of treament: Total costs per patient and average cost per injection

  Up to 20 month

Secondary Outcomes (3)

• Healthcare resource utilization

  Up to 20 months

• Adverse events related to myeloma treatment

  Up to 20 months

• Patients and caregivers' satisfaction

  Up to 20 months

Study Arms (2)

Carfilzomib delivered in OH only

ACTIVE COMPARATOR

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.

Other: Carfilzomib delivered in OH only

Carfilzomib delivered in OH and HaH combined

EXPERIMENTAL

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.

Other: Carfilzomib delivered in OH and HaH combined

Interventions

Carfilzomib delivered in OH only OTHER

Patients receive the whole treatment en OH.

Carfilzomib delivered in OH only

Carfilzomib delivered in OH and HaH combined 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.

Carfilzomib delivered in OH and HaH combined

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Multiple Myeloma

Interventions

hydroxide ion

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Pierre FEUGIER

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreia CARVALHO DE FREITAS

CONTACT

0383859305; a.carvalhodefreitas@chru-nancy.fr

Pierre FEUGIER

CONTACT

0383853283; p.feugier@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: January 11, 2022
• Study Start: January 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: October 30, 2024
• Last Updated: January 11, 2022

Record last verified: 2021-12