FrailtyOnco-ICOPENCT06247189
ICOPE Program Feasibility in the Management of Myeloma Patients
A study testing ICOPE Monitoring in people with Frailty and Multiple Myeloma, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This project proposes to adapt monthly the existing ICOPE (Integrated Care for Older People) MONITOR program for elderly myeloma patients. This adaptation aims to detect earlier functional decline and prevent loss of autonomy. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frailty, Multiple Myeloma
- What is being tested?
- ICOPE Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male or female aged over 70 years,
- Patient with multiple myeloma
- WHO performance status 0-3,
- Patient eligible for first- or second-line treatment
- Patient willing to participate in ICOPE MONITOR program
- Patient or caregiver able to use digital tools of ICOPE MONITOR: application or chatbot (computer or tablet or smartphone)
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- Patient with a life expectancy of more than 3 months,
- Patient or caregiver able to understand, read and speak French
- Person affiliated or benefiting from a social security.
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research)
Who cannot join
- Patient in palliative care
- Patient participating in a study evaluating another frailty prevention program
- Patient unable to understand the study
- Patient under court protection, guardianship or curatorship,
- Patient refusal.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Toulouse
Toulouse
Gilles BOURGADE, 06 04 54 59 39 ext. +33, bourgade.g@chu-toulouse.fr
Stéphanie LOZANO, MD, 05 61 77 66 48 ext. +33, lozano.stephanie@chu-toulouse.fr
About this study
Official title: Onco-ICOPE: ICOPE Program Feasibility in the Management of Myeloma Patients Over 70 Years
This project proposes to adapt monthly the existing ICOPE (Integrated Care for Older People) MONITOR program for elderly myeloma patients. This adaptation aims to detect earlier functional decline and prevent loss of autonomy.
Read the detailed description
With a median age of 70 years at diagnosis, multiple myeloma is a disease of the elderly, with 30-40% of patients over 75 years. Patients identified as frail have a higher risk of mortality, an increase in non-haematological adverse events and a significantly higher risk of treatment discontinuation. Comprehensive geriatric assessment is time-consuming, difficult to follow up regularly, and not routinely offered. However, this population presents an increased risk of loss of autonomy, linked both to age and treatment. For all seniors, ambition of ICOPE (Integrated Care for Older People) program is healthy aging by developing and maintaining their functional ability. To achieve this, the World Health Organization (WHO) recommends monitoring the evolution of intrinsic capacity, every 4 to 6 months. This covers 6 areas: mobility, memory, nutrition, psychological state, vision and hearing. This program is divided into 5 steps (Annex1). Adapting this monitoring to a monthly rhythm will prevent loss of autonomy in this population at greater risk. Early detection allows implementation of early and individualized care plan, thus limiting decline which could prove irreversible.
At inclusion, patient will be included in ICOPE MONITOR program. During this visit, the patient will undergo step 1 of the program, an evaluation of functional autonomy and quality of life, as well as a clinical examination and a collection of hematological data. If anomalies are detected, following steps (2-3-4-5) will be done.
Monthly, patient will carry out a screening (Step1) on his own. In case of abnormalities, following steps can be performed.
Visits will be made every 3 months with a screening (Step1), and if necessary, following steps, an evaluation of autonomy and an evaluation of quality of life.
Patients will be followed for 12 months. At the last visit the patient and the nurse will answer satisfaction questionnaires.
- Conditions
- Frailty, Multiple Myeloma
- Being tested
- ICOPE Monitoring
- Keywords
- ICOPE, multiple myeloma, older patients, follow-up, frailty, geriatric nursing
- Medical subject headings
- Frailty, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICOPE MonitoringOther
At inclusion set up of the ICOPE monitor program on the patient's device and evaluation (all steps) of ICOPE Monitor program.
Monthly, re-evaluation of the patient (Step 1 and others if necessary ) according to the ICOPE Monitor program
| Study group | Role | What they receive |
|---|---|---|
| ICOPE Monitor Program | Experimental | Evaluation at inclusion and re-evaluation monthly. Receives: Other: ICOPE Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the implementation
Feasibility will be assessed on patient adherence to ICOPE MONITOR program. An interruption of 3 or more consecutive Step 1 over one year, apart from death, will be considered a failure of adherence for the patient.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start3 Dec 2025
- Primary completion3 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles BOURGADE, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247189
- Sponsor's protocol ID
- RC31/22/0485
- Acronym
- Onco-ICOPE
- Status last verified
- Dec 2025
- First submitted
- 30 Jan 2024
- Last updated
- 22 Dec 2025
- 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 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onco-ICOPE: ICOPE Program Feasibility in the Management of Myeloma Patients Over 70 Years
- ClinicalTrials.gov ID
- NCT06247189
- Acronym / sponsor ID
- Onco-ICOPE / RC31/22/0485
- Conditions
- Frailty, Multiple Myeloma
- Keywords
- ICOPE, multiple myeloma, older patients, follow-up, frailty, geriatric nursing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 3 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 Feb 2024 (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.
This project proposes to adapt monthly the existing ICOPE (Integrated Care for Older People) MONITOR program for elderly myeloma patients. This adaptation aims to detect earlier functional decline and prevent loss of autonomy.
Detailed description
With a median age of 70 years at diagnosis, multiple myeloma is a disease of the elderly, with 30-40% of patients over 75 years. Patients identified as frail have a higher risk of mortality, an increase in non-haematological adverse events and a significantly higher risk of treatment discontinuation. Comprehensive geriatric assessment is time-consuming, difficult to follow up regularly, and not routinely offered. However, this population presents an increased risk of loss of autonomy, linked both to age and treatment. For all seniors, ambition of ICOPE (Integrated Care for Older People) program is healthy aging by developing and maintaining their functional ability. To achieve this, the World Health Organization (WHO) recommends monitoring the evolution of intrinsic capacity, every 4 to 6 months. This covers 6 areas: mobility, memory, nutrition, psychological state, vision and hearing. This program is divided into 5 steps (Annex1). Adapting this monitoring to a monthly rhythm will prevent loss of autonomy in this population at greater risk. Early detection allows implementation of early and individualized care plan, thus limiting decline which could prove irreversible.
At inclusion, patient will be included in ICOPE MONITOR program. During this visit, the patient will undergo step 1 of the program, an evaluation of functional autonomy and quality of life, as well as a clinical examination and a collection of hematological data. If anomalies are detected, following steps (2-3-4-5) will be done.
Monthly, patient will carry out a screening (Step1) on his own. In case of abnormalities, following steps can be performed.
Visits will be made every 3 months with a screening (Step1), and if necessary, following steps, an evaluation of autonomy and an evaluation of quality of life.
Patients will be followed for 12 months. At the last visit the patient and the nurse will answer satisfaction questionnaires.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICOPE Monitor Program | Experimental | Other: ICOPE MonitoringEvaluation at inclusion and re-evaluation monthly. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Male or female aged over 70 years,
- Patient with multiple myeloma
- WHO performance status 0-3,
- Patient eligible for first- or second-line treatment
- Patient willing to participate in ICOPE MONITOR program
Key exclusion criteria (5 listed)
- Patient in palliative care
- Patient participating in a study evaluating another frailty prevention program
- Patient unable to understand the study
- Patient under court protection, guardianship or curatorship,
- Patient refusal.
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 |
|---|---|---|
| ICOPE MonitoringAt inclusion set up of the ICOPE monitor program on the patient's device and evaluation (all steps) of ICOPE Monitor program. Monthly, re-evaluation of the patient (Step 1 and others if necessary ) according to the ICOPE Monitor program | Other | ICOPE Monitor Program |
Primary outcome
Feasibility of the implementation
Time frame: 12 months
Feasibility will be assessed on patient adherence to ICOPE MONITOR program. An interruption of 3 or more consecutive Step 1 over one year, apart from death, will be considered a failure of adherence for the patient.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Gilles BOURGADE principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICOPE Monitoring in people with Frailty and Multiple Myeloma, run by University Hospital, Toulouse 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 10 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gilles BOURGADE (06 04 54 59 39 ext. +33, bourgade.g@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the implementation (time frame: 12 months). 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 22 Dec 2025.