Multiple MyelomaADHOMYNCT03493737
Cost-Utility Analysis Hospital Versus Home in Multiple Myeloma
An observational study of Multiple Myeloma, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Bortezomib needs repetitive visits at hospital for injections. Hospital-at-Home (HaH) might be an attractive and suitable alternative in this situation. This study aim to perform a cost-utility analysis of two different strategies in several HaH structures within the Grand Est region in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Quality of life surveys
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2018to 15 Feb 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with multiple myeloma requiring a treatment with Bortezomib
Who may be able to join
- Minimum age 18
- Enrolled in a social security scheme
- Diagnosis of multiple myeloma in first line or relapse
- Treatment plan including Bortezomib, adopted in a multidisciplinary meeting in a department of Hematology in Nancy (main investigator), Reims, Strasbourg University Hospitals or Metz-Thionville and Mulhouse local state-run hospitals
- The patients must have agreed to the treatment protocol and to take IV or PO associated drugs prescribed in addition to Bortezomib
- The patients must meet the 2003 eligibility criteria of the National Agency for Accreditation and Evaluation in Health (ANAES) for chemotherapy at home:
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- Absence of severe adaptive or psychological disorders, ability to understand the protocol
- Absence of cognitive impairment
- Availability and agreement of the attending physician
- Home safety and hygiene
- Do not decline to participate in the research and share their personal data
Who cannot join
- Already participating in another trial
- Have a follow-up and/or treatment for another condition requiring a particular care during the Bortezomib treatment period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cost-Utility Evaluation Comparing Hospital Versus Home-Based Bortezomib in Multiple Myeloma: The ADHOMY Study
Bortezomib needs repetitive visits at hospital for injections. Hospital-at-Home (HaH) might be an attractive and suitable alternative in this situation.
This study aim to perform a cost-utility analysis of two different strategies in several HaH structures within the Grand Est region in France.
Read the detailed description
Bortezomib is a standard therapy of newly-diagnosed multiple myeloma and is also approved for relapsing disease, requiring the patients to travel to the outpatient-hospital (OH) once a week for several months. Hospital-at-Home (HaH) might be an attractive and suitable alternative in this situation.
This study aim to perform a cost-utility analysis of two different strategies in several HaH structures within the Grand Est region in France: exclusive hospital-based Bortezomib administration versus combined administration in both OH and HaH.
- Conditions
- Multiple Myeloma
- Being tested
- Quality of life surveys
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life surveysBehavioural
Quality of life surveys by EQ-5D and QLQ-C30
| Study group | Role | What they receive |
|---|---|---|
| HaH (Hospital-at-Home) | Bortezomib is injected at Outpatient hospital at day 1 and at Home at further day of cycles Receives: Behavioral: Quality of life surveys | |
| OH (Outpatient Hospital) | Bortezomib is always injected at Outpatient hospital Receives: Behavioral: Quality of life surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost therapy assessment
Cost therapy assessment including direct medical costs, non-medical costs and indirect costs, investigated from the French Health Insurance perspective and expressed in Euro.
Measured: 10 months follow-up per patient
EQ-5D questionnaire
Measured: 10 months follow-up per patient
QLQ-C30 questionnaire
an oncology-specific instrument
Measured: 10 months follow-up per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start10 Apr 2018
- Primary completion15 Aug 2019
- Study completion15 Feb 2020
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493737
- Sponsor's protocol ID
- 2018-A00103-52
- Acronym
- ADHOMY
- Status last verified
- Aug 2020
- First submitted
- 3 Apr 2018
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Utility Evaluation Comparing Hospital Versus Home-Based Bortezomib in Multiple Myeloma: The ADHOMY Study
- ClinicalTrials.gov ID
- NCT03493737
- Acronym / sponsor ID
- ADHOMY / 2018-A00103-52
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 10 Apr 2018 (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.
Bortezomib needs repetitive visits at hospital for injections. Hospital-at-Home (HaH) might be an attractive and suitable alternative in this situation.
This study aim to perform a cost-utility analysis of two different strategies in several HaH structures within the Grand Est region in France.
Detailed description
Bortezomib is a standard therapy of newly-diagnosed multiple myeloma and is also approved for relapsing disease, requiring the patients to travel to the outpatient-hospital (OH) once a week for several months. Hospital-at-Home (HaH) might be an attractive and suitable alternative in this situation.
This study aim to perform a cost-utility analysis of two different strategies in several HaH structures within the Grand Est region in France: exclusive hospital-based Bortezomib administration versus combined administration in both OH and HaH.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HaH (Hospital-at-Home) | – | Behavioral: Quality of life surveysBortezomib is injected at Outpatient hospital at day 1 and at Home at further day of cycles |
| OH (Outpatient Hospital) | – | Behavioral: Quality of life surveysBortezomib is always injected at Outpatient hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with multiple myeloma requiring a treatment with Bortezomib
Key inclusion criteria (11 listed)
- Minimum age 18
- Enrolled in a social security scheme
- Diagnosis of multiple myeloma in first line or relapse
- Treatment plan including Bortezomib, adopted in a multidisciplinary meeting in a department of Hematology in Nancy (main investigator), Reims, Strasbourg University Hospitals or Metz-Thionville and Mulhouse local state-run hospitals
- The patients must have agreed to the treatment protocol and to take IV or PO associated drugs prescribed in addition to Bortezomib
Key exclusion criteria (2 listed)
- Already participating in another trial
- Have a follow-up and/or treatment for another condition requiring a particular care during the Bortezomib treatment period
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 |
|---|---|---|
| Quality of life surveysQuality of life surveys by EQ-5D and QLQ-C30 | Behavioural | HaH (Hospital-at-Home), OH (Outpatient Hospital) |
Primary outcome
Cost therapy assessment
Time frame: 10 months follow-up per patient
Cost therapy assessment including direct medical costs, non-medical costs and indirect costs, investigated from the French Health Insurance perspective and expressed in Euro.
EQ-5D questionnaire
Time frame: 10 months follow-up per patient
QLQ-C30 questionnaire
Time frame: 10 months follow-up per patient
an oncology-specific instrument
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Central Hospital, Nancy, France at 1 site in 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 11 inclusion and 2 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: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost therapy assessment (time frame: 10 months follow-up per patient). The study lists 3 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 17 Aug 2020.