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NCT Number: NCT07547007

Benefits of a 6-month, Individualized, Hybrid, "Real-life" Adapted Physical Activity Program on the Quality of Life of Patients Treated for Multiple Myeloma

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).

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Key information

Conditions

Multiple Myeloma (MM) Behavior Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Motor Activity Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

61 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Annecy Genevois, Annecy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

adapted physical activity

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    score of functional and symptomatic dimension of EORTC-QLQ-C30 will be calculated and compared between both groups

  2. study the effect of 6 months intervention on objective and subjective level of physical activity

    Time frame: 3 months and 6 months after inclusion

    mean daily time in moderate to elevate intensity during intervention and IPAQ score at 3 and 6 months

  3. study effect of 6 months of intervention on bone pain (FACT-Bone) evolution

    Time frame: 3 and 6 months post inclusion

    compare FACT-Bone pain score at 3 and 6 months betaween both groups

  4. Study effect of 6 months intervention on muscular mass

    Time frame: 6 months post inclusion

    compare between both groups muscular surface on CT scan at L3 level at 6 months

  5. study the effect of 6 months intervention on osteolytic lesion

    Time frame: 6 months post inclusion

    compare evolution of osteolytic lesionnel volume at 6 months between both group

  6. faisability of the intervention in population of interest

    Time frame: from frist intervention day to 6 months

    number realised session in experimental group

  7. study the effect of 6 months intervention on patient tolerance to immunomodulators

    Time frame: from inclusion to end of intervention

    dose adaptation number during 6 months and incidence of gastrointestinal symptoms thanks to NCI-PRO-CTCAE custom survey

  8. study effect of 6 months intervention on immunomodulators treatment response

    Time frame: 3 and 6 months after inclusion

    objective response rate at 3 and 6 months accroding to IMWG

  9. Identification of the factors mediating the improvement in quality of life following the intervention

    Time frame: 0 and 6 months of 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.

  10. safety of the intervention

    Time frame: from 0 to 6 months

    incidence, type, severity, relationship of adverse event and intervention

  11. study effect of 6 months of intervention on disease-specific patient's reported outcomes (FACT-MM)

    Time frame: 3 and 6 months post inclusion

    compare FACT-MM score at 3 and 6 months betaween both groups

Study contacts

Contact information is provided by the study sponsor or research team.

Charlene DUPRE

CONTACT

[email protected]

+33479965910

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Metropole Savoie

Other

Registry information

Official study 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

Acronym: BAPAMM

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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