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

21 december 2021 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

52

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / 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.
Övrig: Carfilzomib delivered in OH only
Patients receive the whole treatment en OH.
Experimentell: 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.
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incremental cost-utility ratio (ICUR) expressed in euros per QALY.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Central Hospital, Nancy, France

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Förväntat)

1 januari 2022

Primärt slutförande (Förväntat)

1 mars 2023

Avslutad studie (Förväntat)

30 oktober 2024

Studieregistreringsdatum

Först inskickad

12 november 2021

Först inskickad som uppfyllde QC-kriterierna

21 december 2021

Första postat (Faktisk)

11 januari 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 januari 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 december 2021

Senast verifierad

1 december 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2020-A00605-34

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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