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

Primary Purpose

Multiple Myeloma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Carfilzomib delivered in OH only
Carfilzomib delivered in OH and HaH combined
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Myeloma focused on measuring Multiple Myeloma, Carfilzomib, Hospital-at-Home (HaH), Outpatient-Hospital (OH), Cost-Utility

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Carfilzomib delivered in OH only

    Carfilzomib delivered in OH and HaH combined

    Arm Description

    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 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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    November 12, 2021
    Last Updated
    December 21, 2021
    Sponsor
    Central Hospital, Nancy, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05184595
    Brief Title
    Cost-Utility Analysis of Home-based Versus Hospital-based Chemotherapy in Multiple Myeloma: Case of Carfilzomib
    Acronym
    ADHOMY2
    Official Title
    Cost-Utility Analysis of Home-based Versus Hospital-based Chemotherapy in Multiple Myeloma: Case of Carfilzomib
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2022 (Anticipated)
    Primary Completion Date
    March 1, 2023 (Anticipated)
    Study Completion Date
    October 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Central Hospital, Nancy, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Myeloma
    Keywords
    Multiple Myeloma, Carfilzomib, Hospital-at-Home (HaH), Outpatient-Hospital (OH), Cost-Utility

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Carfilzomib delivered in OH only
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Carfilzomib delivered in OH and HaH combined
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Carfilzomib delivered in OH only
    Intervention Description
    Patients receive the whole treatment en OH.
    Intervention Type
    Other
    Intervention Name(s)
    Carfilzomib delivered in OH and HaH combined
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Incremental cost-utility ratio (ICUR) expressed in euros per QALY.
    Description
    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)
    Time Frame
    Up to 20 months
    Title
    Differences of quality of life in cancer patients between each group
    Description
    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)
    Time Frame
    Up to 20 months
    Title
    Differences of quality of life in myeloma patients between each group
    Description
    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)
    Time Frame
    Up to 20 months
    Title
    Cost of care
    Description
    Cost for Health Insurance by patients, at the end of treament: Total costs per patient and average cost per injection
    Time Frame
    Up to 20 month
    Secondary Outcome Measure Information:
    Title
    Healthcare resource utilization
    Description
    Rate of emergency visits to the Emergency Room Rate of emergency consultation with the attending physician Call rate in the referring center (Nancy Hospital)
    Time Frame
    Up to 20 months
    Title
    Adverse events related to myeloma treatment
    Description
    Rate of nosocomial infection, neuropathy, digestive disorders Unscheduled hospitalization rates
    Time Frame
    Up to 20 months
    Title
    Patients and caregivers' satisfaction
    Description
    - 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
    Time Frame
    Up to 20 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andreia CARVALHO DE FREITAS
    Phone
    0383859305
    Email
    a.carvalhodefreitas@chru-nancy.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pierre FEUGIER
    Phone
    0383853283
    Email
    p.feugier@chru-nancy.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pierre FEUGIER
    Organizational Affiliation
    Central Hospital, Nancy, France
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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