6-month individualized hybrid adapted physical activity program for people with multiple myeloma
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
This trial will test whether a 6-month individualized program of adapted physical activity, mixing remote home sessions and in-person hospital sessions, can improve quality of life for people over 60 treated for multiple myeloma who are not eligible for transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 61 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Metropole Savoie Academic / other |
| Locations | 2 sites (Annecy and 1 other locations) |
| Trial ID | NCT07547007 on ClinicalTrials.gov |
What this trial studies
Participants are randomized to either a control group that receives advice about physical activity or an interventional group offered a 6-month individualized adapted physical activity program combining remote (home) and in-person hospital sessions. The study measures quality of life as the main outcome and also tracks effort tolerance, pain, muscle mass, osteolytic lesions, treatment tolerance, and treatment response. Eligible patients are those aged over 60 with newly diagnosed or relapsed multiple myeloma (1st to 4th line) who started systemic treatment within the last three months and have scheduled hospital visits as required. The program is delivered at two regional hospitals in France and requires participants to be able to follow protocol procedures and speak French.
Who should consider this trial
Good fit: Ideal candidates are French-speaking patients over 60 with newly diagnosed or relapsed multiple myeloma (1st–4th line) not eligible for transplant who began systemic treatment within the last three months and can attend periodic hospital visits and remote sessions.
Not a fit: Patients with conditions that make exercise unsafe (for example severe cardiac amyloidosis or an absolute contraindication to physical activity), those unable to comply with protocol requirements, non–French speakers, or pregnant/lactating women are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could improve quality of life, increase physical function, reduce pain, and help patients better tolerate multiple myeloma treatments.
How similar studies have performed: Exercise and adapted physical activity programs have improved quality of life and function in many cancer populations, but long-term individualized hybrid programs specifically in multiple myeloma have been less extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Annecy and 1 other locations
- CH Annecy Genevois — Annecy, France (Recruiting)
- CH Métropole Savoie — Chambéry, France (Recruiting)
Study contacts
- Study coordinator: Charlene DUPRE
- Email: charlene.dupre@ch-metropole-savoie.fr
- Phone: +33479965910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.