An interventional study of Adapted exercises and No intervention in Multiple Myeloma, sponsored by Centre Hospitalier Henri Duffaut - Avignon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Centre Hospitalier Henri Duffaut - Avignon · Not applicable, Interventional, and Supportive care
Adapted physical activity for patients with haematological malignancies generally has positive effects on quality of life, fatigue and physical condition. However, some studies show little or no effect.
This may be explained by inefficient protocols, but also by low rates of patient acceptability regarding the proposed exercises.
The multiplicity of APA protocols and the fluctuation of their results mean that validity, methodology and effects on patients need to be verified before they can be considered for implementation in healthcare services. A program must prove its feasibility, but patients must also adhere to it.
Acceptability can be measured by adherence, which represents the number of validated sessions in relation to the number of planned sessions, and by attrition, which corresponds to the number of stops or drop-outs for any reason. The various APA programs offered in the context of intensive auto or allograft treatment are limited, notably by adherence, which can fall by as much as 24%, and attrition, which can be as high as 67%. Optimization of the proposed exercises and follow-up methods is therefore necessary in order to propose an APA program that will be feasible, effective and acceptable to a maximum number of patients.
To meet these objectives for patients with multiple myeloma eligible for autologous stem cell transplantation, the protocol for this study took into consideration the various recommendations of previous publications and the guidelines from HAS (French National Authority for Health).
The ultimate goal of this study is to validate, in terms of effectiveness and acceptability, the methodology and in particular the use of new specific tools for optimizing an APA program. It will subsequently be offered to all patients with multiple myeloma eligible for autologous stem cell transplantation, independently of their age or physical condition, while respecting their rhythm and physical condition.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 120 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Centre Hospitalier Henri Duffaut - Avignon is the lead sponsor of 10 studies on the registry; 5 are open to participants now.
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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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Adapted exercises · Behavioral: Quality of Life questionnaire · Behavioral: Questionnaire of Fatigue · Behavioral: Physical activity questionnaire · Behavioral: Physical condition
Other: No intervention · Behavioral: Quality of Life questionnaire · Behavioral: Questionnaire of Fatigue · Behavioral: Physical activity questionnaire · Behavioral: Physical condition
Patients will have 3 sessions a week: 1 strengthening session and 2 endurance sessions. For each session, patients will choose the exercises to be performed from the exercise booklet or the videos and records their observations in the patient notebook. Depending on the treatment plan, patients will have alternating supervised (in hospital) and unsupervised (at home) APA sessions, in order to follow the rhythm of their visits to the department. Each session will last 45 minutes with a medium intensity according to the Borg scale.
Patients will not be practising adapted exercises as part of the study. They will be treated with chemotherapy according to standard practice.
QoL questionnaire (EORTC QLQ-C30) at baseline, mid-term (after 2 cycles of chemotherapy), before transplantation, and after transplantation
Questionnaire (EORTC QLQ-FA12) at baseline, mid-term (after 2 cycles of chemotherapy), before transplantation, and after transplantation
Questionnaire (IPAQ) at baseline and after transplantation
Evaluation of physical condition at baseline, mid term (after 2 cycles of chemotherapy), before transplantation and after transplantation
Also known as: 30s chair-stand test, Handgrip strength test, 6 minutes walk test
1. Evaluate the effect of the APA program on fatigue status.
Cancer Related Fatigue : EORTC QLQ-FA12 questionnaire (minimum = 0, maximum = 100, higher score means better outcome).
Time frame: Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)
Evaluate the effect of the APA program on quality of life.
Quality of Life of Cancer Patients : EORTC QLQ-C30 questionnaire (minimum = 0, maximum = 100, higher score means better outcome).
Time frame: Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)
Fitness assessment.
6-minute walk test.
Time frame: Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)
Fitness assessment.
30-second chair-stand test.
Time frame: Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)
Fitness assessment.
Hand grip strength test.
Time frame: Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)
Nutritional status.
BMI.
Time frame: Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)
Grade III-IV adverse events rate.
According to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: From inclusion to assessment after transplant (on average about 30 weeks after inclusion)
Comparison of hospitalization length.
Hospitalization time (in days) after autologous stem cell transplantation.
Time frame: Assessment after transplant (on average about 30 weeks after inclusion)
15. Attraction to sport assessment.
IPAQ questionnaire (continuous score expressed as MET-min per week: MET level x minutes of activity/day x days per week, higher score means better outcome)
Time frame: Assessment after transplant (on average about 30 weeks after inclusion)
Adherence rate.
Percentage of patients who participated and validated more than 66 percent of the APA sessions recommended by the program.
Time frame: Assessment after transplant (on average about 30 weeks after inclusion)
Attrition rate.
Percentage of patients who discontinued the program during the course of the study among patients who received an autologous stem cell transplantation.
Time frame: Assessment after transplant (on average about 30 weeks after inclusion)
Rate of effective APA sessions.
Number of validated APA sessions divided by the number of planned sessions.
Time frame: Assessment after transplant (on average about 30 weeks after inclusion)
Reasons for discontinuing the APA program.
Self-reported reasons for discontinuation
Time frame: Assessment after transplant (on average about 30 weeks after inclusion)
Patient's comments and remarks.
Patient's follow-up notebook.
Time frame: 100 days after transplant
Patient satisfaction.
Satisfaction questionnaire. Likert-type scale (minimum = 0, maximum = 4, higher score means better outcome).
Time frame: 100 days after transplant
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Centre Hospitalier Henri Duffaut - Avignon