Recurrent Multiple Myeloma, Refractory Multiple Myeloma
Conditions
Brief 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 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.
Interventions
PROCEDUREAccelerometry
Ancillary studies
OTHERAerobic Exercise
Participate in aerobic training program
PROCEDUREBiospecimen Collection
Undergo collection of blood and urine samples
OTHERElectronic Health Record Review
Ancillary studies
OTHERExercise Counseling
Receive health coaching check-in calls
OTHERInternet-Based Intervention
Use Connected mHealth app
OTHERInterview
Ancillary studies
OTHERPhysical Performance Testing
Ancillary studies
OTHERResistance Training
Participate in resistance training program
OTHERSurvey Administration
Ancillary studies
PROCEDURETailored Intervention
Receive personalized exercise plan
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment rate | Up to 1 year | Enrollment rate will be evaluated as the number of patients eligible versus the number of patients enrolled. |
| Retention rate | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORNadine H. Abdallah, MD
Mayo Clinic
PRINCIPAL_INVESTIGATORDiane K. Ehlers, PhD
Mayo Clinic
Outcome results
None listed