Multiple MyelomaPREHAB-APANCT06789003
Evaluation of a PREHABilitation Protocol Using Adapted Physical Activity (APA) for Multiple Myeloma Patients Eligible for Intensive Autologous Stem Cell Transplantation Treatment
A study testing Adapted exercises, Quality of Life questionnaire and Questionnaire of Fatigue in people with Multiple Myeloma, run by Centre Hospitalier Henri Duffaut - Avignon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Adapted exercises, Quality of Life questionnaire and Questionnaire of Fatigue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2025to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- CML patient in chronic phase, eligible for oral therapy.
- Diagnosis of multiple myeloma.
- Patient eligible for autologous stem cell transplantation.
- Patient capable to read, understand and complete a questionnaire in french.
- WHO less than or equal to 2.
- Patient affiliated with french social security.
- Patient with a medical prescription for APA.
Who cannot join
- Patient with previous cancer within the previous 3 years (except basal cell and squamous cell skin cancers, carcinomas in situ of any type that have been previously resected, and stable prostate or breast cancers more than 3 years old and undergoing adjuvant hormone therapy).
- Medical contraindications to APA (heart failure, angina, unbalanced hypertension, bone metastases, severe osteoporosis, etc.)
- Sensory or motor neuropathy.
- Patient deprived of liberty, under guardianship or curatorship.
- Patient considered socially or psychologically unfit to be enrolled in a study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier d'Avignon, Hôpital Henri Duffaut
Avignon
Marilyne Grinand, PhD, (+33)0432759392, grinand.marilyne@ch-avignon.fr
Emmanuelle Guilie, APA
About this study
Official title: Evaluation of a PREHABilitation Protocol Using Adapted Physical Activity (APA) for Multiple Myeloma Patients Eligible for Intensive Autologous Stem Cell Transplantation Treatment (PREHAB-APA)
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.
Read more
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.
- Conditions
- Multiple Myeloma
- Being tested
- Adapted exercises, No intervention, Quality of Life questionnaire, Questionnaire of Fatigue, Physical activity questionnaire
- Keywords
- Adapted Physical Activity, Autologous stem cell transplantation, Quality of Life, Fatigue
- Medical subject headings
- Multiple Myeloma, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted exercisesOther
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.
No interventionOther
Patients will not be practising adapted exercises as part of the study. They will be treated with chemotherapy according to standard practice.
Quality of Life questionnaireBehavioural
QoL questionnaire (EORTC QLQ-C30) at baseline, mid-term (after 2 cycles of chemotherapy), before transplantation, and after transplantation
Questionnaire of FatigueBehavioural
Questionnaire (EORTC QLQ-FA12) at baseline, mid-term (after 2 cycles of chemotherapy), before transplantation, and after transplantation
Physical activity questionnaireBehavioural
Questionnaire (IPAQ) at baseline and after transplantation
Physical conditionBehavioural
Also called 30s chair-stand test, Handgrip strength test, 6 minutes walk test
Evaluation of physical condition at baseline, mid term (after 2 cycles of chemotherapy), before transplantation and after transplantation
| Study group | Role | What they receive |
|---|---|---|
| APA group | Experimental | Not described Receives: Other: Adapted exercises; Behavioral: Quality of Life questionnaire; Behavioral: Questionnaire of Fatigue; Behavioral: Physical activity questionnaire; Behavioral: Physical condition |
| Control group | Active comparator | Not described Receives: Other: No intervention; Behavioral: Quality of Life questionnaire; Behavioral: Questionnaire of Fatigue; Behavioral: Physical activity questionnaire; Behavioral: Physical condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Secondary outcomes (14)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessment after transplant (on average about 30 weeks after inclusion)
Reasons for discontinuing the APA program.
Self-reported reasons for discontinuation
Measured: Assessment after transplant (on average about 30 weeks after inclusion)
Patient's comments and remarks.
Patient's follow-up notebook.
Measured: 100 days after transplant
Patient satisfaction.
Satisfaction questionnaire. Likert-type scale (minimum = 0, maximum = 4, higher score means better outcome).
Measured: 100 days after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start10 Feb 2025
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Duffaut - Avignon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789003
- Sponsor's protocol ID
- PREHAB-APA
- Acronym
- PREHAB-APA
- Status last verified
- Mar 2026
- First submitted
- 6 Jan 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a PREHABilitation Protocol Using Adapted Physical Activity (APA) for Multiple Myeloma Patients Eligible for Intensive Autologous Stem Cell Transplantation Treatment (PREHAB-APA)
- ClinicalTrials.gov ID
- NCT06789003
- Acronym / sponsor ID
- PREHAB-APA / PREHAB-APA
- Conditions
- Multiple Myeloma
- Keywords
- Adapted Physical Activity, Autologous stem cell transplantation, Quality of Life, Fatigue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Henri Duffaut - AvignonUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APA group | Experimental | Other: Adapted exercises, Behavioral: Quality of Life questionnaire, Behavioral: Questionnaire of Fatigue, Behavioral: Physical activity questionnaire, Behavioral: Physical condition |
| Control group | Active comparator | Other: No intervention, Behavioral: Quality of Life questionnaire, Behavioral: Questionnaire of Fatigue, Behavioral: Physical activity questionnaire, Behavioral: Physical condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years old.
- CML patient in chronic phase, eligible for oral therapy.
- Diagnosis of multiple myeloma.
- Patient eligible for autologous stem cell transplantation.
- Patient capable to read, understand and complete a questionnaire in french.
Key exclusion criteria (5 listed)
- Patient with previous cancer within the previous 3 years (except basal cell and squamous cell skin cancers, carcinomas in situ of any type that have been previously resected, and stable prostate or breast cancers more than 3 years old and undergoing adjuvant hormone therapy).
- Medical contraindications to APA (heart failure, angina, unbalanced hypertension, bone metastases, severe osteoporosis, etc.)
- Sensory or motor neuropathy.
- Patient deprived of liberty, under guardianship or curatorship.
- Patient considered socially or psychologically unfit to be enrolled in a study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted exercisesPatients 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. | Other | APA group |
| No interventionPatients will not be practising adapted exercises as part of the study. They will be treated with chemotherapy according to standard practice. | Other | Control group |
| Quality of Life questionnaireQoL questionnaire (EORTC QLQ-C30) at baseline, mid-term (after 2 cycles of chemotherapy), before transplantation, and after transplantation | Behavioural | APA group, Control group |
| Questionnaire of FatigueQuestionnaire (EORTC QLQ-FA12) at baseline, mid-term (after 2 cycles of chemotherapy), before transplantation, and after transplantation | Behavioural | APA group, Control group |
| Physical activity questionnaireQuestionnaire (IPAQ) at baseline and after transplantation | Behavioural | APA group, Control group |
| Physical conditionAlso: 30s chair-stand test, Handgrip strength test, 6 minutes walk testEvaluation of physical condition at baseline, mid term (after 2 cycles of chemotherapy), before transplantation and after transplantation | Behavioural | APA group, Control group |
Primary outcome
1. Evaluate the effect of the APA program on fatigue status.
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)
Cancer Related Fatigue : EORTC QLQ-FA12 questionnaire (minimum = 0, maximum = 100, higher score means better outcome).
14 secondary outcomes
Evaluate the effect of the APA program on quality of life.
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.
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.
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.
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.
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.
Time frame: From inclusion to assessment after transplant (on average about 30 weeks after inclusion)
Comparison of hospitalization length.
Time frame: Assessment after transplant (on average about 30 weeks after inclusion)
15. Attraction to sport assessment.
Time frame: Assessment after transplant (on average about 30 weeks after inclusion)
Adherence rate.
Time frame: Assessment after transplant (on average about 30 weeks after inclusion)
Attrition rate.
Time frame: Assessment after transplant (on average about 30 weeks after inclusion)
Rate of effective APA sessions.
Time frame: Assessment after transplant (on average about 30 weeks after inclusion)
Reasons for discontinuing the APA program.
Time frame: Assessment after transplant (on average about 30 weeks after inclusion)
Patient's comments and remarks.
Time frame: 100 days after transplant
Patient satisfaction.
Time frame: 100 days after transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted exercises, Quality of Life questionnaire and Questionnaire of Fatigue in people with Multiple Myeloma, run by Centre Hospitalier Henri Duffaut - Avignon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marilyne Grinand, PhD ((+33)432759392, grinand.marilyne@ch-avignon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Evaluate the effect of the APA program on fatigue status. (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.