An interventional study of Adapted physical activity in Multiple Myeloma (MM), sponsored by Centre Hospitalier Metropole Savoie. Recruiting at 2 sites in France. Open to participants aged 61 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Centre Hospitalier Metropole Savoie · Not applicable, Interventional, and Treatment
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.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 86 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Centre Hospitalier Metropole Savoie is the lead sponsor of 22 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Procedure: Adapted physical activity
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.
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
Time frame: 6 months post inclusion
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months post inclusion
faisability of the intervention in population of interest
number realised session in experimental group
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 0 and 6 months of intervention
safety of the intervention
incidence, type, severity, relationship of adverse event and intervention
Time frame: 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
Time frame: 3 and 6 months post inclusion
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Jul 2028, 30 months after the start.
Of 172 non-industry interventional studies with no phase under Multiple Myeloma, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 81. This study's planned 30 months is below that.
Counting every sponsor, half of 186 studies reached it within 38 months; a quarter within 20 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
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Centre Hospitalier Metropole Savoie