Physical ActivityPAMALNCT03946332
Physical Activity for Myeloma Autograft Longitudinal Study
A study testing Physical exercises and Optional physical exercises in people with Physical Activity and Multiple Myeloma, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Physical exercises program is known to improve quality of life, chronical fatigue and appears to be a behavioural recommendation against cancer as primary and tertiary prevention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Physical Activity, Multiple Myeloma, Quality of Life
- What is being tested?
- Physical exercises and Optional physical exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 10 Nov 2020to 17 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Under 65-year-old patient
- more than 18 years old
- Hospitalized for autologous stem cell transplantation
- First or second line therapy for multiple myeloma
- Chemotherapy regimen with melphalan
- Patient affiliated to the social security system
- Signed informed consent form
- Patient who have computer and internet connection at home
Who cannot join
- Over-65-year-old patient
- Other haematological malignancies
- More than 2 treatment lines
- Other regimen of chemotherapy for autograft than melphalan
- Contraindication to physical exercises: uncontrolled arterial hypertension or diabetes, heart or respiratory failure, psycho-cognitive disorders that may compromise the physical exercises program
- dialyzed patient
- Adult patient under tutelage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Exercises for Patient Undergoing Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Controlled Randomised Prospective Multicentre Longitudinal Study.
Physical exercises program is known to improve quality of life, chronical fatigue and appears to be a behavioural recommendation against cancer as primary and tertiary prevention. Nutritional status is also important in cancer patients: a loss of 5% of weight increases the complication risks and decreases survival and the quality of life. Interactions between physical activity and haematological malignancies are less described compared to solid cancers. Methodology and protocols are also heterogeneous. Supervised exercises program improves the physical condition and the quality of life; however there are few randomised studies versus a controlled group. Post autograft evaluation for myeloma patients showed a physical deficit with increased fat mass, but in this particular population physical exercises need to be more explored. This project is a randomised study versus controlled group that evaluates supervised physical exercises program in a homogenous population: patients under-65-years-old with multiple myeloma and who will undergo autologous stem cell transplantation.
Read the detailed description
Physical exercises program is known to improve quality of life, chronical fatigue and appears to be a behavioural recommendation against cancer as primary and tertiary prevention. Nutritional status is also important in cancer patients: a loss of 5% of weight increases the complication risks and decreases survival and the quality of life. Interactions between physical activity and haematological malignancies are less described compared to solid cancers. This multicentre project is a randomised study versus controlled group that evaluates supervised physical exercises program in a homogenous population: patients under-65-years-old with multiple myeloma and who will undergo autologous stem cell transplantation. The hypothesis of this study is that a supervised physical exercises program during and after autograft might have a positive impact on the physical capacities and the quality of life.
In the experimental arm, patients will benefit regularly from a physical exercises program during their hospitalization. When going back home, they will be given a practical help kit with specific equipment (dumbbell, elastic), an actimeter with heart rate monitoring (in order to have an objective collection of the physical practice in addition to a self-evaluation) and a physical exercises program on paper and video supports, that patients would have learnt during their hospitalization. Furthermore, SMS will be regularly sent to remind them to practice. In the controlled arm, patients will be hospitalized in the same conditions than the experimental group and can practice if they want. At the end of the hospitalization, they will receive a paper document with global informations about physical exercises including a few simple exercises. Evaluations will be carried out in both arms at day 0, day 30 and day 90 from autograft. The post graft follow up will be done at the same time as the medical consultation and before the maintenance treatment.
- Conditions
- Physical Activity, Multiple Myeloma, Quality of Life
- Being tested
- Physical exercises, Optional physical exercises
- Keywords
- physical activity, multiple myeloma, autologous stem cell transplantation, quality of life, physical conditioning
- Medical subject headings
- Motor Activity, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercisesBehavioural
patients will benefit regularly from a physical exercises program during their hospitalization. When going back home, they will be given a practical help kit with specific equipment (dumbbell, elastic), an actimeter with heart rate monitoring (in order to have an objective collection of the physical practice in addition to a self-evaluation) and a physical exercises program on paper and video supports, that patients would have learnt during their hospitalization.
Optional physical exercisesBehavioural
patients will be proposed for the physical exercises and will practice them if they want.
| Study group | Role | What they receive |
|---|---|---|
| Physical exercise arm | Experimental | patients will benefit regularly from a physical exercises program during their hospitalization. When going back home, they will be given a practical help kit with specific equipment (dumbbell, elastic), an actimeter with heart rate monitoring (in order to have an objective collection of the physical practice in addition to a self-evaluation) and a physical exercises program on paper and video supports, that patients would have learnt during their hospitalization. Furthermore, SMS will be regularly sent to remind them to practice Receives: Behavioral: Physical exercises |
| controlled arm | Active comparator | patients will be hospitalized in the same conditions than the experimental group and will be able to practice if they want. Receives: Behavioral: Optional physical exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of quality of life with EORTC QLQ-C30 questionnaire
The quality of life will be measure with the EORTC quality QLQ-C30 questionnaire to assess the quality of life of cancer patients. Scales range in score is from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Measured: at day 0 from autograft as patient will be hospitalized.
Measure of quality of life with EORTC QLQ-C30 questionnaire
The quality of life will be measure with the EORTC quality QLQ-C30 questionnaire to assess the quality of life of cancer patients. Scales range in score is from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Measured: at day 30 from autograft as patient will be hospitalized.
Measure of quality of life with EORTC QLQ-C30 questionnaire
The quality of life will be measure with the EORTC quality QLQ-C30 questionnaire to assess the quality of life of cancer patients. Scales range in score is from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Measured: at day 90 from autograft as patient will be hospitalized.
Measure of quality of life with QLQ-MY20 questionnaire
The quality of life will be measure with the QLQ-MY20 questionnaire to assess the quality of life of cancer patients.
QLQ-MY20 domain scores are averaged and transformed linearly to a score ranging from 0-100. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.
Measured: at day 0 from autograft as patient will be hospitalized.
Measure of quality of life measured with QLQ-MY20 questionnaire
The quality of life will be measure with the QLQ-MY20 questionnaire to assess the quality of life of cancer patients.
QLQ-MY20 domain scores are averaged and transformed linearly to a score ranging from 0-100. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.
Measured: at day 30 from autograft as patient will be hospitalized.
Measure of quality of life measured with QLQ-MY20 questionnaire
The quality of life will be measure with the QLQ-MY20 questionnaire to assess the quality of life of cancer patients.
QLQ-MY20 domain scores are averaged and transformed linearly to a score ranging from 0-100. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.
Measured: at day 90 from autograft as patient will be hospitalized.
Secondary outcomes (3)
Measure of fatigue evaluated by Piper scale
The Piper Fatigue Scale is composed of 22 numerically scaled, "0" to "10" items that measure four dimensions of subjective fatigue. This will give an average score that remains on the same "0" to "10"numeric scale. O is the moderate score and 10 is the worst score.
Measured: at day 0 from autograft as patient will be hospitalized.
Measure of fatigue evaluated by Piper scale
The Piper Fatigue Scale is composed of 22 numerically scaled, "0" to "10" items that measure four dimensions of subjective fatigue. This will give an average score that remains on the same "0" to "10"numeric scale. O is the moderate score and 10 is the worst score.
Measured: at day 30 from autograft as patient will be hospitalized.
Measure of fatigue evaluated by Piper scale
The Piper Fatigue Scale is composed of 22 numerically scaled, "0" to "10" items that measure four dimensions of subjective fatigue. This will give an average score that remains on the same "0" to "10"numeric scale. O is the moderate score and 10 is the worst score.
Measured: at day 90 from autograft as patient will be hospitalized.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start10 Nov 2020
- Primary completion17 May 2026
- Study completion17 May 2026
Why it stopped: The study has stopped after the investigator's decision. The latter desires to analyse the collected data at 60 patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Rouen, University Hospital, Caen
- Responsible party
- Sponsor
- Investigators
- caroline delette, MD, Principal investigator, CHU AmiensPierre Morel, MD, Principal investigator, CHU AmiensFabrice Jardin, Pr, Principal investigator, CHU RouenOana Brehar, MD, Principal investigator, CHU RouenVincent Camus, MD, Principal investigator, CHU RouenNathalie Cardinael, MD, Principal investigator, CHU RouenNathalie Contentin, MD, Principal investigator, CHU RouenMarie-Laure Fontoura, MD, Principal investigator, CHU Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946332
- Sponsor's protocol ID
- PI2018_843_0008
- Acronym
- PAMAL
- Status last verified
- May 2026
- First submitted
- 9 May 2019
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercises for Patient Undergoing Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Controlled Randomised Prospective Multicentre Longitudinal Study.
- ClinicalTrials.gov ID
- NCT03946332
- Acronym / sponsor ID
- PAMAL / PI2018_843_0008
- Conditions
- Physical Activity, Multiple Myeloma, Quality of Life
- Keywords
- physical activity, multiple myeloma, autologous stem cell transplantation, quality of life, physical conditioning
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has stopped after the investigator's decision. The latter desires to analyse the collected data at 60 patients.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- University Hospital, Rouen, University Hospital, Caen
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 17 May 2026 (actual)
- Study completion
- 17 May 2026 (actual)
- First posted
- 10 May 2019 (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.
Physical exercises program is known to improve quality of life, chronical fatigue and appears to be a behavioural recommendation against cancer as primary and tertiary prevention. Nutritional status is also important in cancer patients: a loss of 5% of weight increases the complication risks and decreases survival and the quality of life. Interactions between physical activity and haematological malignancies are less described compared to solid cancers. Methodology and protocols are also heterogeneous. Supervised exercises program improves the physical condition and the quality of life; however there are few randomised studies versus a controlled group. Post autograft evaluation for myeloma patients showed a physical deficit with increased fat mass, but in this particular population physical exercises need to be more explored. This project is a randomised study versus controlled group that evaluates supervised physical exercises program in a homogenous population: patients under-65-years-old with multiple myeloma and who will undergo autologous stem cell transplantation.
Detailed description
Physical exercises program is known to improve quality of life, chronical fatigue and appears to be a behavioural recommendation against cancer as primary and tertiary prevention. Nutritional status is also important in cancer patients: a loss of 5% of weight increases the complication risks and decreases survival and the quality of life. Interactions between physical activity and haematological malignancies are less described compared to solid cancers. This multicentre project is a randomised study versus controlled group that evaluates supervised physical exercises program in a homogenous population: patients under-65-years-old with multiple myeloma and who will undergo autologous stem cell transplantation. The hypothesis of this study is that a supervised physical exercises program during and after autograft might have a positive impact on the physical capacities and the quality of life.
In the experimental arm, patients will benefit regularly from a physical exercises program during their hospitalization. When going back home, they will be given a practical help kit with specific equipment (dumbbell, elastic), an actimeter with heart rate monitoring (in order to have an objective collection of the physical practice in addition to a self-evaluation) and a physical exercises program on paper and video supports, that patients would have learnt during their hospitalization. Furthermore, SMS will be regularly sent to remind them to practice. In the controlled arm, patients will be hospitalized in the same conditions than the experimental group and can practice if they want. At the end of the hospitalization, they will receive a paper document with global informations about physical exercises including a few simple exercises. Evaluations will be carried out in both arms at day 0, day 30 and day 90 from autograft. The post graft follow up will be done at the same time as the medical consultation and before the maintenance treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical exercise arm | Experimental | Behavioral: Physical exercisespatients will benefit regularly from a physical exercises program during their hospitalization. When going back home, they will be given a practical help kit with specific equipment (dumbbell, elastic), an actimeter with heart rate monitoring (in order to have an objective collection of the physical practice in addition to a self-evaluation) and a physical exercises program on paper and video supports, that patients would have learnt during their hospitalization. Furthermore, SMS will be regularly sent to remind them to practice |
| controlled arm | Active comparator | Behavioral: Optional physical exercisespatients will be hospitalized in the same conditions than the experimental group and will be able to practice if they want. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Under 65-year-old patient
- more than 18 years old
- Hospitalized for autologous stem cell transplantation
- First or second line therapy for multiple myeloma
- Chemotherapy regimen with melphalan
Key exclusion criteria (7 listed)
- Over-65-year-old patient
- Other haematological malignancies
- More than 2 treatment lines
- Other regimen of chemotherapy for autograft than melphalan
- Contraindication to physical exercises: uncontrolled arterial hypertension or diabetes, heart or respiratory failure, psycho-cognitive disorders that may compromise the physical exercises program
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 |
|---|---|---|
| Physical exercisespatients will benefit regularly from a physical exercises program during their hospitalization. When going back home, they will be given a practical help kit with specific equipment (dumbbell, elastic), an actimeter with heart rate monitoring (in order to have an objective collection of the physical practice in addition to a self-evaluation) and a physical exercises program on paper and video supports, that patients would have learnt during their hospitalization. | Behavioural | Physical exercise arm |
| Optional physical exercisespatients will be proposed for the physical exercises and will practice them if they want. | Behavioural | controlled arm |
Primary outcome
Measure of quality of life with EORTC QLQ-C30 questionnaire
Time frame: at day 0 from autograft as patient will be hospitalized.
The quality of life will be measure with the EORTC quality QLQ-C30 questionnaire to assess the quality of life of cancer patients. Scales range in score is from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Measure of quality of life with EORTC QLQ-C30 questionnaire
Time frame: at day 30 from autograft as patient will be hospitalized.
The quality of life will be measure with the EORTC quality QLQ-C30 questionnaire to assess the quality of life of cancer patients. Scales range in score is from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Measure of quality of life with EORTC QLQ-C30 questionnaire
Time frame: at day 90 from autograft as patient will be hospitalized.
The quality of life will be measure with the EORTC quality QLQ-C30 questionnaire to assess the quality of life of cancer patients. Scales range in score is from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Measure of quality of life with QLQ-MY20 questionnaire
Time frame: at day 0 from autograft as patient will be hospitalized.
The quality of life will be measure with the QLQ-MY20 questionnaire to assess the quality of life of cancer patients. QLQ-MY20 domain scores are averaged and transformed linearly to a score ranging from 0-100. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.
Measure of quality of life measured with QLQ-MY20 questionnaire
Time frame: at day 30 from autograft as patient will be hospitalized.
The quality of life will be measure with the QLQ-MY20 questionnaire to assess the quality of life of cancer patients. QLQ-MY20 domain scores are averaged and transformed linearly to a score ranging from 0-100. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.
Measure of quality of life measured with QLQ-MY20 questionnaire
Time frame: at day 90 from autograft as patient will be hospitalized.
The quality of life will be measure with the QLQ-MY20 questionnaire to assess the quality of life of cancer patients. QLQ-MY20 domain scores are averaged and transformed linearly to a score ranging from 0-100. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.
3 secondary outcomes
Measure of fatigue evaluated by Piper scale
Time frame: at day 0 from autograft as patient will be hospitalized.
Measure of fatigue evaluated by Piper scale
Time frame: at day 30 from autograft as patient will be hospitalized.
Measure of fatigue evaluated by Piper scale
Time frame: at day 90 from autograft as patient will be hospitalized.
Results and safety
The study was stopped early (reason given: The study has stopped after the investigator's decision. The latter desires to analyse the collected data at 60 patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
Related trials for Physical Activity
RecruitingPhase 1
Imatinib to Increase RUNX1 Activity in Participants With Germline RUNX1 Deficiency
Inherited Bone Marrow Failure Syndrome, Familial Platelet Disorder With Predisposition to Myeloid Malignancies
Active, not recruitingObservational study
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
Colitis, Ulcerative
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Not yet recruitingObservational study
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
Primary Biliary Cholangitis (PBC)
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. This study is not recruiting at the moment.
caroline delette, MD principal investigator
CHU Amiens
Pierre Morel, MD principal investigator
CHU Amiens
Fabrice Jardin, Pr principal investigator
CHU Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercises and Optional physical exercises in people with Physical Activity and Multiple Myeloma, run by Centre Hospitalier Universitaire, Amiens 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 7 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: stopped early, as of the sponsor's last update on 28 May 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?
The study was stopped early (reason given: The study has stopped after the investigator's decision. The latter desires to analyse the collected data at 60 patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of quality of life with EORTC QLQ-C30 questionnaire (time frame: at day 0 from autograft as patient will be hospitalized.). The study lists 6 primary outcomes in all. 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 28 May 2026.