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

21. desember 2021 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Forventet)

52

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Annen: Carfilzomib delivered in OH only
Patients receive the whole treatment en OH.
Eksperimentell: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incremental cost-utility ratio (ICUR) expressed in euros per QALY.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Healthcare resource utilization
Tidsramme: 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
Tidsramme: Up to 20 months
  • Rate of nosocomial infection, neuropathy, digestive disorders
  • Unscheduled hospitalization rates
Up to 20 months
Patients and caregivers' satisfaction
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Central Hospital, Nancy, France

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. januar 2022

Primær fullføring (Forventet)

1. mars 2023

Studiet fullført (Forventet)

30. oktober 2024

Datoer for studieregistrering

Først innsendt

12. november 2021

Først innsendt som oppfylte QC-kriteriene

21. desember 2021

Først lagt ut (Faktiske)

11. januar 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. januar 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. desember 2021

Sist bekreftet

1. desember 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2020-A00605-34

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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