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

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].

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 Overview

• Status: Recruiting
• Conditions: Multiple Myeloma (MM)
• Intervention / Treatment: Procedure: Adapted physical activity

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charlene DUPRE; Phone Number: +33479965910; Email: charlene.dupre@ch-metropole-savoie.fr

Study Locations

• France
  • Annecy, France, 74374
    • Recruiting
    • Ch Annecy Genevois
    • Principal Investigator: Adrien CONTEJEAN
    • Contact: Marie LEBOUC; Phone Number: +33450637136; Email: mlebouc@ch-annecygenevois.fr
  • Chambéry, France, 73000
    • Recruiting
    • CH Métropole Savoie
    • Contact: Arthur DONY; Phone Number: +33479965105; Email: arthur.dony@ch-metropole-savoie.fr
    • Principal Investigator: Antoine SAUTHIER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; 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: Experimental group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months post inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	6 months post inclusion
faisability of the intervention in population of interest	number realised session in experimental group	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	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	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.	0 and 6 months of intervention
safety of the intervention	incidence, type, severity, relationship of adverse event and intervention	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	3 and 6 months post inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Metropole Savoie

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 30, 2028

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: physical activity; multiple myeloma; control group
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Behavior; Hemic and Lymphatic Diseases; Multiple Myeloma; Motor Activity
• Other Study ID Numbers: CHMS25006; 2025-A01123-46 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No