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Cost-Utility Analysis of Home-based Versus Hospital-based Chemotherapy in Multiple Myeloma: Case of Carfilzomib (ADHOMY2)

21 december 2021 bijgewerkt door: Pierre FEUGIER, Central Hospital, Nancy, France

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

52

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Ander: Carfilzomib delivered in OH only
Patients receive the whole treatment en OH.
Experimenteel: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incremental cost-utility ratio (ICUR) expressed in euros per QALY.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Healthcare resource utilization
Tijdsspanne: Up to 20 months
  • Rate of emergency visits to the Emergency Room
  • Rate of emergency consultation with the attending physician
  • Call rate in the referring center (Nancy Hospital)
Up to 20 months
Adverse events related to myeloma treatment
Tijdsspanne: Up to 20 months
  • Rate of nosocomial infection, neuropathy, digestive disorders
  • Unscheduled hospitalization rates
Up to 20 months
Patients and caregivers' satisfaction
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Central Hospital, Nancy, France

Onderzoekers

  • Hoofdonderzoeker: Pierre FEUGIER, Central Hospital, Nancy, France

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Verwacht)

1 januari 2022

Primaire voltooiing (Verwacht)

1 maart 2023

Studie voltooiing (Verwacht)

30 oktober 2024

Studieregistratiedata

Eerst ingediend

12 november 2021

Eerst ingediend dat voldeed aan de QC-criteria

21 december 2021

Eerst geplaatst (Werkelijk)

11 januari 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 januari 2022

Laatste update ingediend die voldeed aan QC-criteria

21 december 2021

Laatst geverifieerd

1 december 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2020-A00605-34

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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