Recurrent Multiple MyelomaNCT07045727
Prehabilitation With Aerobic and Resistance Exercise for Improving Physical Fitness and Quality of Life Outcomes in Older Patients Undergoing CAR-T Therapy for Relapsed or Refractory Multiple Myeloma
A study testing Accelerometry, Aerobic Exercise and Biospecimen Collection in people with Recurrent Multiple Myeloma and Refractory Multiple Myeloma, run by Mayo Clinic at 1 site in United States.
Trial summary
This clinical trial evaluates whether prehabilitation with aerobic and resistance exercise improves physical fitness and quality of life outcomes in older patients planning to undergo chimeric antigen receptor (CAR)-T therapy for multiple myeloma that has come back after a period of improvement (relapsed) or that does… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Recurrent Multiple Myeloma, Refractory Multiple Myeloma
- What is being tested?
- Accelerometry, Aerobic Exercise and Biospecimen Collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to 16 Jun 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple myeloma diagnosis
- Females and males ≥ 60 years of age
- Eastern Cooperative Oncology Group (ECOG) score of < 3
- Scheduled for a CAR T therapy transfusion
- Apheresis date at least 7 days prior to date of enrollment
- Primary hematologist attending physician clearance for exercise
Who cannot join
- Females or males < 60 years of age
- Any hematological cancer other than multiple myeloma
- Evidence of an absolute contraindication [e.g., heart insufficiency > New York Heart Association (NYHA) III or uncertain arrhythmia; uncontrolled hypertension; reduced standing or walking ability for exercise]
- Other comorbidities that preclude participation in the exercise as deemed by physical therapist or physical medicine and rehabilitation (PM\&R) physician
- Active infections, active bleeding disorders, and cytopenias at risk for further adverse events deemed by hematologist-oncologist
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Prehabilitation in Patients With Multiple Myeloma Receiving CAR-T Therapy
This clinical trial evaluates whether prehabilitation with aerobic and resistance exercise improves physical fitness and quality of life outcomes in older patients planning to undergo chimeric antigen receptor (CAR)-T therapy for multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). CAR-T therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. Large numbers of the CAR-T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. While CAR-T therapy is commonly used to treat multiple myeloma, it can result in toxicities that lead to hospitalization, nerve and muscle impairment, and decreased physical function. Prehabilitation programs use targeted interventions to improve functional status prior to medical or surgical treatments. In this study, patients participate in personalized aerobic and resistance prehabilitation activities in the weeks leading up to their CAR-T infusion. This program may improve physical fitness and quality of life, both prior to and after CAR-T infusion, in older patients with relapsed or refractory multiple myeloma.
- Being tested
- Accelerometry, Aerobic Exercise, Biospecimen Collection, Electronic Health Record Review, Exercise Counseling
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccelerometryProcedure or surgery
Ancillary studies
Aerobic ExerciseOther
Also called Aerobic Activity
Participate in aerobic training program
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood and urine samples
Electronic Health Record ReviewOther
Ancillary studies
Exercise CounselingOther
Receive health coaching check-in calls
Internet-Based InterventionOther
Use Connected mHealth app
InterviewOther
Ancillary studies
Physical Performance TestingOther
Also called Physical Fitness Testing, Physical Function Testing
Ancillary studies
Resistance TrainingOther
Also called Strength Training
Participate in resistance training program
Survey AdministrationOther
Ancillary studies
Tailored InterventionProcedure or surgery
Receive personalized exercise plan
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (aerobic and resistance training) | Experimental | Patients receive a personalized exercise plan and use the Connected mHealth app to participate in aerobic and resistance training, according to exercise guidelines and their personalized plan, for 6 weeks. Patients also receive health coaching check-in calls weekly for 6 weeks. Patients also undergo collection of blood and urine samples throughout the study. Receives: Procedure: Accelerometry; Other: Aerobic Exercise; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Exercise Counseling; Other: Internet-Based Intervention; Other: Interview; Other: Physical Performance Testing; Other: Resistance Training; Other: Survey Administration; Procedure: Tailored Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
Enrollment rate will be evaluated as the number of patients eligible versus the number of patients enrolled.
Measured: Up to 1 year
Retention rate
Retention rate will be evaluated as the proportion of enrolled patients who complete assessments at visit 2 (at 2 days prior to CAR-T infusion) and visit 3 (30 days post-CAR-T infusion).
Measured: Up to 30 days post-chimeric antigen receptor (CAR)-T infusion
Program completion
Will be evaluated according to the completion of weekly phone calls, the frequency, intensity, and duration of exercise engagement, and accelerometer summary outcomes. The program will be considered feasible if there is > 70% program completion, based on weekly phone calls.
Measured: Up to 30 days post-CAR-T infusion
Incidence of adverse events
The program will be considered feasible if there are no serious adverse events due to the intervention.
Measured: Up to 30 days post-CAR-T infusion
Patient satisfaction
Patient satisfaction will be determined using post-program satisfaction phone interviews. Qualitative interviews will be analyzed using thematic analysis.
Measured: Up to 30 days post-CAR-T infusion
Change in muscle strength
Assessed as grip strength, as measured (in kg) by maximal force generated by forearm muscles using calibrated handheld dynamometer
Measured: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Change in muscle mass
Assessed via SOZO by ImpediMed [bioimpedance spectroscopy (BIS)] and Positron Emission Tomography (PET) Computed Tomography (CT) CT scan images, obtained as part of the patient's usual care.
Measured: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Change in physical performance
Assessed via short physical performance test (approximately 90 minutes) followed by wearing an activity monitor (Actigraph) for 7 days following each of 3 in-person physical assessments. Participants receive a postage-paid envelope to return the monitor after wearing it.
Measured: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Change in quality of life - EORTC QLQ-C30
Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, a 30-item questionnaire where 28 questions are answered on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, and 4= very much) and 2 two questions are answered on a scale of 1-7 (1= very poor and 7=excellent). Higher summary scores indicate better health related quality of life.
Measured: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Change in physical activity - monitor
Assessed using Polar heart rate monitor with data collected through the Connected mHealth app.
Measured: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Change in physical activity - RPE Scale
Assessed using patient self-reported Rate of Perceived Exertion (RPE) scale score within the Connected mHealth app after exercise: 1=very light activity; 2-3=light activity; 4-5=moderate activity; 7-8=vigorous activity; 9=very hard activity; and 10=maximal effort.
Measured: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Changes in frailty status - IMWG-FI
Assessed using International Myeloma Working Group (IMWG) Frailty Index (FI) scores. The IMWG-FI assigns scores based on age, comorbidities, and the ability to perform activities of daily living (ADL) and instrumental activities of daily living (IADL). Patients are categorized as follows: Fit: Score of 0; Intermediate-fit: Score of 1; Frail: Score of 2 or higher.
Measured: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Changes in frailty status - FP
The Fried frailty phenotype (FP) defines frailty as the presence of three or more of the following: unintentional weight loss ≥10 lb in previous year; self-reported exhaustion; weakness measured by grip strength; slow walking speed ;and low physical activity (less than 3 days of physical activity per week defined by the Department of Health Services \& Human Services). The presence of: 1) ≥3 criteria indicates frail status, 2) 1 or 2 criteria indicates intermediate or pre-frail status, and 3) 0 criteria indicates robust status.
Measured: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start18 Aug 2025
- Primary completion16 Jun 2026
- Study completion16 Jun 2026
Why it stopped: Limited funding, slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadine H. Abdallah, MD, Principal investigator, Mayo ClinicDiane K. Ehlers, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045727
- Sponsor's protocol ID
- 25-001845
- Other IDs
- NCI-2025-04165, 25-001845
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2025
- Last updated
- 1 Jul 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation in Patients With Multiple Myeloma Receiving CAR-T Therapy
- ClinicalTrials.gov ID
- NCT07045727
- Acronym / sponsor ID
- 25-001845
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limited funding, slow accrual
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 16 Jun 2026 (actual)
- Study completion
- 16 Jun 2026 (actual)
- First posted
- 1 Jul 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.
This clinical trial evaluates whether prehabilitation with aerobic and resistance exercise improves physical fitness and quality of life outcomes in older patients planning to undergo chimeric antigen receptor (CAR)-T therapy for multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). CAR-T therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. Large numbers of the CAR-T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. While CAR-T therapy is commonly used to treat multiple myeloma, it can result in toxicities that lead to hospitalization, nerve and muscle impairment, and decreased physical function. Prehabilitation programs use targeted interventions to improve functional status prior to medical or surgical treatments. In this study, patients participate in personalized aerobic and resistance prehabilitation activities in the weeks leading up to their CAR-T infusion. This program may improve physical fitness and quality of life, both prior to and after CAR-T infusion, in older patients with relapsed or refractory multiple myeloma.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (aerobic and resistance training) | Experimental | Procedure: Accelerometry, Other: Aerobic Exercise, Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Other: Exercise Counseling, Other: Internet-Based Intervention, Other: Interview, Other: Physical Performance Testing, Other: Resistance Training, Other: Survey Administration, Procedure: Tailored InterventionPatients receive a personalized exercise plan and use the Connected mHealth app to participate in aerobic and resistance training, according to exercise guidelines and their personalized plan, for 6 weeks. Patients also receive health coaching check-in calls weekly for 6 weeks. Patients also undergo collection of blood and urine samples throughout the study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Multiple myeloma diagnosis
- Females and males ≥ 60 years of age
- Eastern Cooperative Oncology Group (ECOG) score of < 3
- Scheduled for a CAR T therapy transfusion
- Apheresis date at least 7 days prior to date of enrollment
Key exclusion criteria (5 listed)
- Females or males < 60 years of age
- Any hematological cancer other than multiple myeloma
- Evidence of an absolute contraindication [e.g., heart insufficiency > New York Heart Association (NYHA) III or uncertain arrhythmia; uncontrolled hypertension; reduced standing or walking ability for exercise]
- Other comorbidities that preclude participation in the exercise as deemed by physical therapist or physical medicine and rehabilitation (PM\&R) physician
- Active infections, active bleeding disorders, and cytopenias at risk for further adverse events deemed by hematologist-oncologist
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 |
|---|---|---|
| AccelerometryAncillary studies | Procedure or surgery | Supportive care (aerobic and resistance training) |
| Aerobic ExerciseAlso: Aerobic ActivityParticipate in aerobic training program | Other | Supportive care (aerobic and resistance training) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood and urine samples | Procedure or surgery | Supportive care (aerobic and resistance training) |
| Electronic Health Record ReviewAncillary studies | Other | Supportive care (aerobic and resistance training) |
| Exercise CounselingReceive health coaching check-in calls | Other | Supportive care (aerobic and resistance training) |
| Internet-Based InterventionUse Connected mHealth app | Other | Supportive care (aerobic and resistance training) |
| InterviewAncillary studies | Other | Supportive care (aerobic and resistance training) |
| Physical Performance TestingAlso: Physical Fitness Testing, Physical Function TestingAncillary studies | Other | Supportive care (aerobic and resistance training) |
| Resistance TrainingAlso: Strength TrainingParticipate in resistance training program | Other | Supportive care (aerobic and resistance training) |
| Survey AdministrationAncillary studies | Other | Supportive care (aerobic and resistance training) |
| Tailored InterventionReceive personalized exercise plan | Procedure or surgery | Supportive care (aerobic and resistance training) |
Primary outcome
Enrollment rate
Time frame: Up to 1 year
Enrollment rate will be evaluated as the number of patients eligible versus the number of patients enrolled.
Retention rate
Time frame: Up to 30 days post-chimeric antigen receptor (CAR)-T infusion
Retention rate will be evaluated as the proportion of enrolled patients who complete assessments at visit 2 (at 2 days prior to CAR-T infusion) and visit 3 (30 days post-CAR-T infusion).
Program completion
Time frame: Up to 30 days post-CAR-T infusion
Will be evaluated according to the completion of weekly phone calls, the frequency, intensity, and duration of exercise engagement, and accelerometer summary outcomes. The program will be considered feasible if there is > 70% program completion, based on weekly phone calls.
Incidence of adverse events
Time frame: Up to 30 days post-CAR-T infusion
The program will be considered feasible if there are no serious adverse events due to the intervention.
Patient satisfaction
Time frame: Up to 30 days post-CAR-T infusion
Patient satisfaction will be determined using post-program satisfaction phone interviews. Qualitative interviews will be analyzed using thematic analysis.
Change in muscle strength
Time frame: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed as grip strength, as measured (in kg) by maximal force generated by forearm muscles using calibrated handheld dynamometer
Change in muscle mass
Time frame: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed via SOZO by ImpediMed [bioimpedance spectroscopy (BIS)] and Positron Emission Tomography (PET) Computed Tomography (CT) CT scan images, obtained as part of the patient's usual care.
Change in physical performance
Time frame: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed via short physical performance test (approximately 90 minutes) followed by wearing an activity monitor (Actigraph) for 7 days following each of 3 in-person physical assessments. Participants receive a postage-paid envelope to return the monitor after wearing it.
Change in quality of life - EORTC QLQ-C30
Time frame: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, a 30-item questionnaire where 28 questions are answered on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, and 4= very much) and 2 two questions are answered on a scale of 1-7 (1= very poor and 7=excellent). Higher summary scores indicate better health related quality of life.
Change in physical activity - monitor
Time frame: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed using Polar heart rate monitor with data collected through the Connected mHealth app.
Change in physical activity - RPE Scale
Time frame: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed using patient self-reported Rate of Perceived Exertion (RPE) scale score within the Connected mHealth app after exercise: 1=very light activity; 2-3=light activity; 4-5=moderate activity; 7-8=vigorous activity; 9=very hard activity; and 10=maximal effort.
Changes in frailty status - IMWG-FI
Time frame: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
Assessed using International Myeloma Working Group (IMWG) Frailty Index (FI) scores. The IMWG-FI assigns scores based on age, comorbidities, and the ability to perform activities of daily living (ADL) and instrumental activities of daily living (IADL). Patients are categorized as follows: Fit: Score of 0; Intermediate-fit: Score of 1; Frail: Score of 2 or higher.
Changes in frailty status - FP
Time frame: Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3)
The Fried frailty phenotype (FP) defines frailty as the presence of three or more of the following: unintentional weight loss ≥10 lb in previous year; self-reported exhaustion; weakness measured by grip strength; slow walking speed ;and low physical activity (less than 3 days of physical activity per week defined by the Department of Health Services \& Human Services). The presence of: 1) ≥3 criteria indicates frail status, 2) 1 or 2 criteria indicates intermediate or pre-frail status, and 3) 0 criteria indicates robust status.
Results and safety
The study was stopped early (reason given: Limited funding, slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nadine H. Abdallah, MD principal investigator
Mayo Clinic
Diane K. Ehlers, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerometry, Aerobic Exercise and Biospecimen Collection in people with Recurrent Multiple Myeloma and Refractory Multiple Myeloma, run by Mayo Clinic at 1 site in United States.
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 6 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: stopped early, as of the sponsor's last update on 1 Jul 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 United States. 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: Limited funding, slow accrual). 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?
Enrollment rate (time frame: Up to 1 year). The study lists 13 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 1 Jul 2026.