Multiple Myeloma (MM)BAPAMMNCT07547007
Benefits of a 6-month, Individualized, Hybrid, "Real-life" Adapted Physical Activity Program on the Quality of Life of Patients Treated for Multiple Myeloma
A study testing Adapted physical activity in people with Multiple Myeloma (MM), run by Centre Hospitalier Metropole Savoie at 2 sites in France.
Trial summary
The goal of this clinical trial is to evaluate the effect of a long-term, individualized, hybrid adapted physical activity program on the quality of life of patients with multiple myeloma. Read more about this study
- Who is it for?
- Ages 61 years and older
- Conditions the study is for
- Multiple Myeloma (MM)
- What is being tested?
- Adapted physical activity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Jan 2026to 30 Jul 2028
- 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 61 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly diagnosed or relapse multiple myeloma, > 60 yo, not eligible to transplant
- 1st to 4th line of treatment initiated during the last 3 months
- receiving a systemic treatment that involved visit to the hospital at least twice a month durig the first 3 months and at least once a month the next 3 months
Who cannot join
- severe cardiac amyloidosis
- absolute contraindication to physical activity
- inability to comply with the protocol requirements
- not french speaker
- patient under guardianship or curatorship
- pregnant or lactating women
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CH Annecy Genevois
Annecy, 74374
Marie LEBOUC, +33450637136, mlebouc@ch-annecygenevois.fr
Adrien CONTEJEAN
- Recruiting
CH Métropole Savoie
Chambéry, 73000
Arthur DONY, +33479965105, arthur.dony@ch-metropole-savoie.fr
Antoine SAUTHIER
About this study
Official title: Benefits of a 6-month, Individualized, Hybrid, "Real-life" Adapted Physical Activity Program on the Quality of Life of Patients Treated for Multiple Myeloma: a Multicenter Randomized Controlled Trial
The goal of this clinical trial is to evaluate the effect of a long-term, individualized, hybrid adapted physical activity program on the quality of life of patients with multiple myeloma. The main question it aims to answer are :
Does this logn term, individualized and hybrid adapted physical activity program improve quality of life in multiple myeloma patient ? What are the effects of this program on effort tolerance, pain, muscular mass, osteolytic lesions, tolerance to treatment, response to treatment? If there is a comparison group: Researchers will compare [arm information] to see if [insert effects].
Read more
Participants will be randomised in 2 groups.
- control group: patients will receive only advices about physical activities benefit
- interventional group: This group will be offered a program of adapted physical activities mixing sessions at home (remote) and sessions at the hospital (in person).
- Conditions
- Multiple Myeloma (MM)
- Being tested
- Adapted physical activity
- Keywords
- physical activity, multiple myeloma, control group
- Medical subject headings
- Multiple Myeloma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted physical activityProcedure or surgery
the intervention is a "real life"6 months adapted physical activity program which is individualised and hybrid (presential and distancial) . It includes a session in presential (at hospital) every 2 weeks for the first 3 months then once a month and 3 sessions par week for 6 months at home.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | patient will receive advices about benefit to practice physical activity, only once at the beginning of their treatment. Evaluation including 6 minutes walk test, chair stand test, gait-speed test, evaluation of maximum isometric strength of the quadriceps, quality of lif questionnaries, PRO, treatment tolerance, response evaluation will be held at inclusion, 3 months later and 6 months later. |
| Experimental group | Experimental | patient will follow an adapted physical activity program with presential (every 2 weeks the first 3 months, then once a month for 3 months) and distancial (3 times per week for 6 months) sessions.Evaluation including 6 minutes walk test, chair stand test, gait-speed test, evaluation of maximum isometric strength of the quadriceps, quality of lif questionnaries, PRO, treatment tolerance, response evaluation will be held at inclusion, 3 months later and 6 months later. Receives: Procedure: Adapted physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare EORTC-QLQ-C30 summary score at 6 months between both groups
EORTC-QLQ-C30 questionnaire will be given to participant at inclusion and at 6 months, score will be calculated
Measured: 6 months post inclusion
Secondary outcomes (11)
compare functional and symptomatic dimension of EORTC-QLQ-C30 at 3 and 6 months between both groups
score of functional and symptomatic dimension of EORTC-QLQ-C30 will be calculated and compared between both groups
Measured: 3 and 6 months after inclusion
study the effect of 6 months intervention on objective and subjective level of physical activity
mean daily time in moderate to elevate intensity during intervention and IPAQ score at 3 and 6 months
Measured: 3 months and 6 months after inclusion
study effect of 6 months of intervention on bone pain (FACT-Bone) evolution
compare FACT-Bone pain score at 3 and 6 months betaween both groups
Measured: 3 and 6 months post inclusion
Study effect of 6 months intervention on muscular mass
compare between both groups muscular surface on CT scan at L3 level at 6 months
Measured: 6 months post inclusion
study the effect of 6 months intervention on osteolytic lesion
compare evolution of osteolytic lesionnel volume at 6 months between both group
Measured: 6 months post inclusion
faisability of the intervention in population of interest
number realised session in experimental group
Measured: from frist intervention day to 6 months
study the effect of 6 months intervention on patient tolerance to immunomodulators
dose adaptation number during 6 months and incidence of gastrointestinal symptoms thanks to NCI-PRO-CTCAE custom survey
Measured: from inclusion to end of intervention
study effect of 6 months intervention on immunomodulators treatment response
objective response rate at 3 and 6 months accroding to IMWG
Measured: 3 and 6 months after inclusion
Identification of the factors mediating the improvement in quality of life following the intervention
Multivariate analysis including the changes of quality of life (before/after intervention) as dependant variable and changes in exercise tolerance (6-minutes walking distance), Bone pain (FACT-Bone Pain), muscle mass (L3 section on CT-scan), osteolytic lesion on CT-scan and tolerance to immunomodulators as independant variables. The variables selection will be based on stepwise regression.
Measured: 0 and 6 months of intervention
safety of the intervention
incidence, type, severity, relationship of adverse event and intervention
Measured: from 0 to 6 months
study effect of 6 months of intervention on disease-specific patient's reported outcomes (FACT-MM)
compare FACT-MM score at 3 and 6 months betaween both groups
Measured: 3 and 6 months post inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start22 Jan 2026
- Primary completionJul 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Metropole Savoie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547007
- Sponsor's protocol ID
- CHMS25006
- Other IDs
- 2025-A01123-46
- Acronym
- BAPAMM
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 23 Apr 2026
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of a 6-month, Individualized, Hybrid, "Real-life" Adapted Physical Activity Program on the Quality of Life of Patients Treated for Multiple Myeloma: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07547007
- Acronym / sponsor ID
- BAPAMM / CHMS25006
- Conditions
- Multiple Myeloma (MM)
- Keywords
- physical activity, multiple myeloma, control group
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Centre Hospitalier Metropole SavoieUniversity, hospital or other
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 23 Apr 2026 (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 goal of this clinical trial is to evaluate the effect of a long-term, individualized, hybrid adapted physical activity program on the quality of life of patients with multiple myeloma. The main question it aims to answer are :
Does this logn term, individualized and hybrid adapted physical activity program improve quality of life in multiple myeloma patient ? What are the effects of this program on effort tolerance, pain, muscular mass, osteolytic lesions, tolerance to treatment, response to treatment? If there is a comparison group: Researchers will compare [arm information] to see if [insert effects].
Participants will be randomised in 2 groups.
- control group: patients will receive only advices about physical activities benefit
- interventional group: This group will be offered a program of adapted physical activities mixing sessions at home (remote) and sessions at the hospital (in person).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –patient will receive advices about benefit to practice physical activity, only once at the beginning of their treatment. Evaluation including 6 minutes walk test, chair stand test, gait-speed test, evaluation of maximum isometric strength of the quadriceps, quality of lif questionnaries, PRO, treatment tolerance, response evaluation will be held at inclusion, 3 months later and 6 months later. |
| Experimental group | Experimental | Procedure: Adapted physical activitypatient will follow an adapted physical activity program with presential (every 2 weeks the first 3 months, then once a month for 3 months) and distancial (3 times per week for 6 months) sessions.Evaluation including 6 minutes walk test, chair stand test, gait-speed test, evaluation of maximum isometric strength of the quadriceps, quality of lif questionnaries, PRO, treatment tolerance, response evaluation will be held at inclusion, 3 months later and 6 months later. |
Who may qualify
- Ages
- 61 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- newly diagnosed or relapse multiple myeloma, > 60 yo, not eligible to transplant
- 1st to 4th line of treatment initiated during the last 3 months
- receiving a systemic treatment that involved visit to the hospital at least twice a month durig the first 3 months and at least once a month the next 3 months
Key exclusion criteria (6 listed)
- severe cardiac amyloidosis
- absolute contraindication to physical activity
- inability to comply with the protocol requirements
- not french speaker
- patient under guardianship or curatorship
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 |
|---|---|---|
| Adapted physical activitythe intervention is a "real life"6 months adapted physical activity program which is individualised and hybrid (presential and distancial) . It includes a session in presential (at hospital) every 2 weeks for the first 3 months then once a month and 3 sessions par week for 6 months at home. | Procedure or surgery | Experimental group |
Primary outcome
compare EORTC-QLQ-C30 summary score at 6 months between both groups
Time frame: 6 months post inclusion
EORTC-QLQ-C30 questionnaire will be given to participant at inclusion and at 6 months, score will be calculated
11 secondary outcomes
compare functional and symptomatic dimension of EORTC-QLQ-C30 at 3 and 6 months between both groups
Time frame: 3 and 6 months after inclusion
study the effect of 6 months intervention on objective and subjective level of physical activity
Time frame: 3 months and 6 months after inclusion
study effect of 6 months of intervention on bone pain (FACT-Bone) evolution
Time frame: 3 and 6 months post inclusion
Study effect of 6 months intervention on muscular mass
Time frame: 6 months post inclusion
study the effect of 6 months intervention on osteolytic lesion
Time frame: 6 months post inclusion
faisability of the intervention in population of interest
Time frame: from frist intervention day to 6 months
study the effect of 6 months intervention on patient tolerance to immunomodulators
Time frame: from inclusion to end of intervention
study effect of 6 months intervention on immunomodulators treatment response
Time frame: 3 and 6 months after inclusion
Identification of the factors mediating the improvement in quality of life following the intervention
Time frame: 0 and 6 months of intervention
safety of the intervention
Time frame: from 0 to 6 months
study effect of 6 months of intervention on disease-specific patient's reported outcomes (FACT-MM)
Time frame: 3 and 6 months post inclusion
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 23 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma (MM)
RecruitingPhase 1
A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
Relapsed or Refractory Multiple Myeloma
RecruitingPhase 3
A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
High Risk Smoldering Multiple Myeloma (HR-SMM)
RecruitingPhase 1
Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers
AML, Multiple Myeloma
Not yet recruitingPhase 1
Engineered Dendritic Cell Vaccines for Multiple Myeloma
Multiple Myeloma or Plasmacytoma
RecruitingPhase 1
ELEVATE-MM: Elotuzumab, Iberdomide and Dexamethasone Post Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma
Myeloma, Multiple Myeloma
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted physical activity in people with Multiple Myeloma (MM), run by Centre Hospitalier Metropole Savoie at 2 sites 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 3 inclusion and 6 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 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Charlene DUPRE (+33479965910, charlene.dupre@ch-metropole-savoie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare EORTC-QLQ-C30 summary score at 6 months between both groups (time frame: 6 months post inclusion). 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 23 Apr 2026.