Multiple MyelomaADHOMY2NCT05184595
Cost-Utility Analysis of Home-based Versus Hospital-based Chemotherapy in Multiple Myeloma: Case of Carfilzomib
A study testing Carfilzomib delivered in OH only and Carfilzomib delivered in OH and HaH combined in people with Multiple Myeloma, run by Central Hospital, Nancy, France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Carfilzomib delivered in OH only and Carfilzomib delivered in OH and HaH combined
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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).
Read more
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Carfilzomib delivered in OH only, Carfilzomib delivered in OH and HaH combined
- Keywords
- Multiple Myeloma, Carfilzomib, Hospital-at-Home (HaH), Outpatient-Hospital (OH), Cost-Utility
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carfilzomib delivered in OH onlyOther
Patients receive the whole treatment en OH.
Carfilzomib delivered in OH and HaH combinedOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Carfilzomib delivered in OH only | Active comparator | 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. Receives: Other: Carfilzomib delivered in OH only |
| Carfilzomib delivered in OH and HaH combined | Experimental | 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. Receives: Other: Carfilzomib delivered in OH and HaH combined |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 20 months
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)
Measured: Up to 20 months
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)
Measured: Up to 20 months
Cost of care
Cost for Health Insurance by patients, at the end of treament: Total costs per patient and average cost per injection
Measured: Up to 20 month
Secondary outcomes (3)
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)
Measured: Up to 20 months
Adverse events related to myeloma treatment
- Rate of nosocomial infection, neuropathy, digestive disorders
- Unscheduled hospitalization rates
Measured: Up to 20 months
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
Measured: Up to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jan 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre FEUGIER, Central Hospital, Nancy, France
- Investigators
- Pierre FEUGIER, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184595
- Sponsor's protocol ID
- 2020-A00605-34
- Acronym
- ADHOMY2
- Status last verified
- Dec 2021
- First submitted
- 12 Nov 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Utility Analysis of Home-based Versus Hospital-based Chemotherapy in Multiple Myeloma: Case of Carfilzomib
- ClinicalTrials.gov ID
- NCT05184595
- Acronym / sponsor ID
- ADHOMY2 / 2020-A00605-34
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Carfilzomib, Hospital-at-Home (HaH), Outpatient-Hospital (OH), Cost-Utility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carfilzomib delivered in OH only | Active comparator | Other: Carfilzomib delivered in OH onlyPatients 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. |
| Carfilzomib delivered in OH and HaH combined | Experimental | Other: Carfilzomib delivered in OH and HaH combinedPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carfilzomib delivered in OH onlyPatients receive the whole treatment en OH. | Other | Carfilzomib delivered in OH only |
| Carfilzomib delivered in OH and HaH combinedPatients 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. | Other | Carfilzomib delivered in OH and HaH combined |
Primary outcome
Incremental cost-utility ratio (ICUR) expressed in euros per QALY.
Time frame: 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)
Differences of quality of life in cancer patients between each group
Time frame: 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)
Differences of quality of life in myeloma patients between each group
Time frame: 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)
Cost of care
Time frame: Up to 20 month
Cost for Health Insurance by patients, at the end of treament: Total costs per patient and average cost per injection
3 secondary outcomes
Healthcare resource utilization
Time frame: Up to 20 months
Adverse events related to myeloma treatment
Time frame: Up to 20 months
Patients and caregivers' satisfaction
Time frame: Up to 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre FEUGIER principal investigator
Central Hospital, Nancy, France
Questions about this trial
What is this clinical trial studying?
A study testing Carfilzomib delivered in OH only and Carfilzomib delivered in OH and HaH combined in people with Multiple Myeloma, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreia CARVALHO DE FREITAS (0383859305, a.carvalhodefreitas@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental cost-utility ratio (ICUR) expressed in euros per QALY. (time frame: Up to 20 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.