Multiple MyelomaPAMM-HAD1NCT03490084
Impacts on Health Outcomes and Resources Utilization of Hospital-at-home for Elderly Patients With Multiple Myeloma
An observational study of Multiple Myeloma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The study aims to compare the overall survival adjusted to quality of life of 2 groups of patients with multiple myeloma, depending on the type of care: (1) day hospitalization exclusively or (2) day hospitalization combined with hospital-at-home. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Association of day hospitalization with hospital-at-home and Day hospitalization exclusively
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2020to Oct 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patient aged > 65 years, with symptomatic multiple myeloma, ineligible for autologous hematopoietic stem-cell transplantation, planned to undergo treatments including bortezomib.
Who may be able to join
- Patient > 65 years;
- Resident of the departments in Île-de-France region (75, 92, 93 and 94);
- Symptomatic multiple myeloma (relapsed or no);
- Patient planned to receive one of the following chemotherapy protocols including bortezomib (VELCADE®): VMP (Velcade, Melphalan, Prednisone), VCD (Velcade, Cyclophosphamide, Dexamethasone), VelDex (Velcade, Dexamethasone), VRD (Velcade, Revlimid, Dexamethasone);
- Ineligible for autologous hematopoietic stem-cell transplantation (ASCT);
- Covered by a health insurance;
- Patient who does not oppose to the use of his/her medical data for the purpose of clinical research.
- Adult patients under guardianship will can be enrolled in the study, a consent of tutor is needed completed by patient's consent.
Who cannot join
- Resident of the departments of 77, 78 and 91 in Île-de-France region;
- Asymptomatic myeloma;
- Life expectancy < 6 months;
- Patient does not understand French language.
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to compare the overall survival adjusted to quality of life of 2 groups of patients with multiple myeloma, depending on the type of care: (1) day hospitalization exclusively or (2) day hospitalization combined with hospital-at-home.
As secondary objectives, the study aims to compare the impacts of the two types of care organization on:
Read more
- the survival of patients and response to treatments according to criteria of the International Myeloma Working Group,
- psychological status of patients,
- specific toxicity related to treatment used (haematological and infectious toxicity, neurotoxicity, ...),
- health outcomes,
- the caregiver's burden,
This study is combined with a qualitative study about the incentives and the barriers, and in order to set up the patient's typology.
Read the detailed description
Multiple myeloma, a malignant blood disease with about 5000 new cases diagnosed annually in France, essentially in the elderly population, is associated with alteration of quality of life resulting from pathology and therapies.
Multiples cycles of chemotherapies are administered in a regular manner, as outpatient treatment or day hospitalization.
In this study aiming to explore the impacts on health outcomes and resources utilization of hospital-at-home for elderly patients with multiple myeloma, all patients will be treated by 4 standardized protocols of treatment including bortezomib by subcutaneous administration.
9 centers will participate to the study. The study will not change the usual practices of care of these centers:
- 6 centers organize patient care through day hospitalization combined with hospital-at-home,
- 3 other centers rely exclusively on day hospitalization.
The study will target overall the inclusion of 300 patients for the 9 centers and 70 participants (35 for each arm: 10 patients, 10 caregivers, 15 from healthcare team) for the qualitative study.
The individual follow up of each patient will last 12 months. The patient's vital status will be documented at the 24th month.
- Conditions
- Multiple Myeloma
- Being tested
- Association of day hospitalization with hospital-at-home, Day hospitalization exclusively
- Keywords
- multiple myeloma, elderly patients, health outcomes, hospital-at-home, day hospitalization, quality of life, medico-economic evaluation, qualitative study
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Association of day hospitalization with hospital-at-homeOther
Patients receive the first administration of chemotherapy through day hospitalization in the hematology department, then 3 weekly administrations of chemotherapy at home.
Day hospitalization exclusivelyOther
Patients receive 4 weekly administrations of chemotherapy through day hospitalization in the hematology department.
| Study group | Role | What they receive |
|---|---|---|
| Association of day hospitalization with hospital-at-home | Patients receive the first administration of chemotherapy through day hospitalization in the hematology department, then 3 weekly administrations of chemotherapy at home. Receives: Other: Association of day hospitalization with hospital-at-home | |
| Day hospitalization exclusively | Patients receive 4 weekly administrations of chemotherapy through day hospitalization in the hematology department. Receives: Other: Day hospitalization exclusively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of life using questionnaires EORTC QLQ-30
Comparison of quality of life using questionnaires EORTC QLQ-30.
Measured: At baseline, at the 6th month and the 12th month
Change in Quality of life using questionnaires EORTC QLQ-MY20
Comparison of quality of life using questionnaires EORTC QLQ-MY20.
Measured: At baseline, at the 6th month and the 12th month
Secondary outcomes (6)
Survival
All patients will be evaluated in order to collect the following data:
- death and causality with multiple myeloma, treatments;
- progression or relapse according to criteria of International Myeloma Working Group;
- survival without progression, full or partial remission.
Measured: At the 1st day of each chemotherapy cycle (each cycle varying between 28 and 35 days)
Multidimensional evaluation of home care
RAI-HC (Resident Assessment Instrument Home Care) will be used at home. Multidimensional evaluation involves 19 areas such as sociodemographic, environmental and clinical endpoints with psychological status, cognitive status, morbidity and medication compliance defined by validated synthetic clinical scales.
Measured: At baseline, at the 6th month
Toxicity of treatment
This evaluation will be performed for all patients with the National Cancer Institute Common Terminology Criteria for Adverse Events (CRCAE version 3.0).
Measured: At baseline, at each evaluation of response to therapy, at the 6th month and the 12th month
family quality of life
Family quality of life will be evaluated with Zarit Burden Inventory
Measured: At baseline, at the 6th month and the 12th month
Total Cost
The following costs will be collected: hospitalization, home care, transport, biological exams, costs of chemotherapy (bortezomib) as well as indirect costs such as paid sick leave and salary of caregiver at home.
Measured: At the end of study: 3 years
Fate-to-face interview with patients, caregivers and healthcare staff
The assessment criteria are the quality care, the continuity of care, the coordination between the care actors, the information transmission, the incentives and the barriers according to the forms of hospitalization.
Measured: At baseline, at the 6th month and the 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start25 Feb 2020
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (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 Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bénédicte MITTAINE-MARZAC, PharmD, Study chair, Hospitalisation à domicile (HAD), APHPMatthieu de STAMPA, MD, Study director, Hospitalisation à domicile (HAD), APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490084
- Sponsor's protocol ID
- K160917J
- Other IDs
- 2017-A03219-44
- Acronym
- PAMM-HAD1
- Status last verified
- Aug 2023
- First submitted
- 26 Feb 2018
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts on Health Outcomes and Resources Utilization of Hospital-at-home for Elderly Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03490084
- Acronym / sponsor ID
- PAMM-HAD1 / K160917J
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, elderly patients, health outcomes, hospital-at-home, day hospitalization, quality of life, medico-economic evaluation, qualitative study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 6 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.
The study aims to compare the overall survival adjusted to quality of life of 2 groups of patients with multiple myeloma, depending on the type of care: (1) day hospitalization exclusively or (2) day hospitalization combined with hospital-at-home.
As secondary objectives, the study aims to compare the impacts of the two types of care organization on:
- the survival of patients and response to treatments according to criteria of the International Myeloma Working Group,
- psychological status of patients,
- specific toxicity related to treatment used (haematological and infectious toxicity, neurotoxicity, ...),
- health outcomes,
- the caregiver's burden,
This study is combined with a qualitative study about the incentives and the barriers, and in order to set up the patient's typology.
Detailed description
Multiple myeloma, a malignant blood disease with about 5000 new cases diagnosed annually in France, essentially in the elderly population, is associated with alteration of quality of life resulting from pathology and therapies.
Multiples cycles of chemotherapies are administered in a regular manner, as outpatient treatment or day hospitalization.
In this study aiming to explore the impacts on health outcomes and resources utilization of hospital-at-home for elderly patients with multiple myeloma, all patients will be treated by 4 standardized protocols of treatment including bortezomib by subcutaneous administration.
9 centers will participate to the study. The study will not change the usual practices of care of these centers:
- 6 centers organize patient care through day hospitalization combined with hospital-at-home,
- 3 other centers rely exclusively on day hospitalization.
The study will target overall the inclusion of 300 patients for the 9 centers and 70 participants (35 for each arm: 10 patients, 10 caregivers, 15 from healthcare team) for the qualitative study.
The individual follow up of each patient will last 12 months. The patient's vital status will be documented at the 24th month.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Association of day hospitalization with hospital-at-home | – | Other: Association of day hospitalization with hospital-at-homePatients receive the first administration of chemotherapy through day hospitalization in the hematology department, then 3 weekly administrations of chemotherapy at home. |
| Day hospitalization exclusively | – | Other: Day hospitalization exclusivelyPatients receive 4 weekly administrations of chemotherapy through day hospitalization in the hematology department. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patient aged > 65 years, with symptomatic multiple myeloma, ineligible for autologous hematopoietic stem-cell transplantation, planned to undergo treatments including bortezomib.
Key inclusion criteria (8 listed)
- Patient > 65 years;
- Resident of the departments in Île-de-France region (75, 92, 93 and 94);
- Symptomatic multiple myeloma (relapsed or no);
- Patient planned to receive one of the following chemotherapy protocols including bortezomib (VELCADE®): VMP (Velcade, Melphalan, Prednisone), VCD (Velcade, Cyclophosphamide, Dexamethasone), VelDex (Velcade, Dexamethasone), VRD (Velcade, Revlimid, Dexamethasone);
- Ineligible for autologous hematopoietic stem-cell transplantation (ASCT);
Key exclusion criteria (4 listed)
- Resident of the departments of 77, 78 and 91 in Île-de-France region;
- Asymptomatic myeloma;
- Life expectancy < 6 months;
- Patient does not understand French language.
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 |
|---|---|---|
| Association of day hospitalization with hospital-at-homePatients receive the first administration of chemotherapy through day hospitalization in the hematology department, then 3 weekly administrations of chemotherapy at home. | Other | Association of day hospitalization with hospital-at-home |
| Day hospitalization exclusivelyPatients receive 4 weekly administrations of chemotherapy through day hospitalization in the hematology department. | Other | Day hospitalization exclusively |
Primary outcome
Change in Quality of life using questionnaires EORTC QLQ-30
Time frame: At baseline, at the 6th month and the 12th month
Comparison of quality of life using questionnaires EORTC QLQ-30.
Change in Quality of life using questionnaires EORTC QLQ-MY20
Time frame: At baseline, at the 6th month and the 12th month
Comparison of quality of life using questionnaires EORTC QLQ-MY20.
6 secondary outcomes
Survival
Time frame: At the 1st day of each chemotherapy cycle (each cycle varying between 28 and 35 days)
Multidimensional evaluation of home care
Time frame: At baseline, at the 6th month
Toxicity of treatment
Time frame: At baseline, at each evaluation of response to therapy, at the 6th month and the 12th month
family quality of life
Time frame: At baseline, at the 6th month and the 12th month
Total Cost
Time frame: At the end of study: 3 years
Fate-to-face interview with patients, caregivers and healthcare staff
Time frame: At baseline, at the 6th month and the 12th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
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RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Active, not recruitingPhase 1/2
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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.
Bénédicte MITTAINE-MARZAC, PharmD study chair
Hospitalisation à domicile (HAD), APHP
Matthieu de STAMPA, MD study director
Hospitalisation à domicile (HAD), APHP
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 Assistance Publique - Hôpitaux de Paris 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 8 inclusion and 4 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 28 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bénédicte MITTAINE-MARZAC, PharmD (+33 1 42 34 84 15, benedicte.mittaine-marzac@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of life using questionnaires EORTC QLQ-30 (time frame: At baseline, at the 6th month and the 12th month). The study lists 2 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 28 Aug 2023.