What's the purpose of this trial?
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.
This trial is currently open and accepting patients.
What will happen during the trial?
You may be able to join this trial if you:
The following criteria is a partial list of reasons why patients may be
eligible to participate in this clinical trial. Further evaluation with a medical professional is
required.
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
Additional Trial Information
Enrollment: 20 patients (estimated)
View More
