This clinical trial investigates the effect of non-chemotherapeutic interventions in patients with multiple myeloma, plasma cell leukemia (PCL) or low risk myelodysplastic syndrome (MDS). Non-chemotherapeutic interventions such as physical activity and nutritional interventions (e.g., modifications in diet) have been shown to positively affect the immune system and improve overall quality of life. Another purpose of this study is for researchers to learn how the addition of a beta-blocker (propranolol) to the standard treatment regimen in patients with newly diagnosed multiple myeloma affects immune response and quality of life. A study from the Mayo Clinic looked at multiple myeloma patients who were on a beta-blocker while undergoing chemotherapy and found that the use of a beta-blocker resulted in improved patient survival outcomes. Non-chemotherapeutic treatment options may help decrease symptoms and improve quality of life for patients with multiple myeloma, PCL or low risk MDS.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05312255.
Locations matching your search criteria
United States
New York
Buffalo
Roswell Park Cancer InstituteStatus: Active
Contact: Jens Hillengass
Phone: 716-845-5280
PRIMARY OBJECTIVE:
I. To assess the impact of different lifestyle and low side effect interventions (exercise, nutrition, stress effects reduction) on immune markers in patients with monoclonal plasma cell and other hematologic disorders.
SECONDARY OBJECTIVES:
I. To assess the impact of different lifestyle and low side effect interventions (exercise, nutrition) on bone turnover parameters, body composition, the microbiome and physical fitness in patients with monoclonal plasma cell and other hematologic disorders.
II. To assess the impact of different lifestyle and low side effect interventions (exercise, nutrition, stress effect reduction) on parameters of stress, mental health and quality of life in patients with monoclonal plasma cell and other hematologic disorders.
EXPLORATORY OBJECTIVES:
I. To assess the impact of different lifestyle and low side effect interventions (exercise, nutrition, stress reduction) on response to therapy in patients with monoclonal plasma cell disorders.
II. Cross-cohort comparison of changes in immune cells, microbiome, bone markers, body composition and psychological markers.
III. Evaluate measures of clinical efficacy.
OUTLINE: Patients are assigned to Module A, B, C or D.
MODULE A: Patients undergo strength training sessions twice weekly supervised by a licensed and specialized personal trainer via the internet (e.g., remote access) for 6 months. Patients also wear a FitBit device and receive prompts via email or text on a cell phone or other electronic device to incrementally increase physical activity over 6 months. Patients also undergo dual X-ray absorptiometry (DEXA) scans on study and collection of blood samples throughout the trial.
MODULE B: Patients undergo intermittent fasting for 1 month. This consists of restricting all eating to a consecutive 8-hour time period each day followed by 16 consecutive hours of not eating. Patients also undergo DEXA scans on study and collection of blood samples throughout the trial.
MODULE C: Patients receive propranolol orally (PO) twice daily (BID) for 3 months. Patients also undergo collection of blood samples throughout the trial.
MODULE D: Patients undergo strength training sessions twice weekly supervised by a licensed and specialized personal trainer via the internet (e.g., remote access) for 6 months. Patients also wear a FitBit device and receive prompts via email or text on a cell phone or other electronic device to incrementally increase physical activity over 6 months. Patients also undergo DEXA scans on study and collection of blood samples throughout the trial.
After completion of the study interventions, patients in module A and D are followed every 3 months for 1 year. Patients in module B are followed at 3 and 5 months. Patients in module C are followed for 3 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationRoswell Park Cancer Institute
Principal InvestigatorJens Hillengass