Cost-Utility Analysis of Home-based Versus Hospital-based Chemotherapy in Multiple Myeloma: Case of Carfilzomib (ADHOMY2)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: ANDREIA CARVALHO DE FREITAS
- Numéro de téléphone: 0383859305
- E-mail: a.carvalhodefreitas@chru-nancy.fr
Sauvegarde des contacts de l'étude
- Nom: Pierre FEUGIER
- Numéro de téléphone: 0383853283
- E-mail: p.feugier@chru-nancy.fr
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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. |
Patients receive the whole treatment en OH.
|
|
Expérimental: 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. |
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incremental cost-utility ratio (ICUR) expressed in euros per QALY.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Healthcare resource utilization
Délai: Up to 20 months
|
|
Up to 20 months
|
|
Adverse events related to myeloma treatment
Délai: Up to 20 months
|
|
Up to 20 months
|
|
Patients and caregivers' satisfaction
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Pierre FEUGIER, Central Hospital, Nancy, France
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies cardiovasculaires
- Maladies vasculaires
- Maladies du système immunitaire
- Tumeurs par type histologique
- Tumeurs
- Troubles lymphoprolifératifs
- Troubles immunoprolifératifs
- Maladies hématologiques
- Troubles hémorragiques
- Troubles hémostatiques
- Paraprotéinémies
- Troubles des protéines sanguines
- Myélome multiple
- Tumeurs, plasmocyte
Autres numéros d'identification d'étude
- 2020-A00605-34
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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