NCT05312255

Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma

Improving Host Factors in Patients With Monoclonal Gammopathies and Other Hematologic Disorders

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (estimated)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial investigates the effect of non-chemotherapeutic interventions in patients with multiple myeloma or 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.

Detailed description

PRIMARY OBJECTIVES: 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. OUTLINE: Patients are assigned to Module A, B C or D. (MDS patients will only be assigned in Module 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. 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. MODULE C: Patients are assigned to group 1 (are not currently taking beta-blockers) or group 2 (current taking beta-blockers). GROUP I: Patients receive propranolol orally (PO) twice daily (BID) for 3 months. GROUP II: Patients continue receiving beta-blocker regimen as per standard of care (SOC) for 3 months. MODULE D: Patients will receive resistance training twice a week for 6 months. After completion of the study interventions, patients in module A 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.

Conditions

• Plasma Cell Myeloma
• Recurrent Plasma Cell Myeloma
• Refractory Plasma Cell Myeloma
• Smoldering Plasma Cell Myeloma

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Intervention	Wear a FitBit device and receive prompts for 6 months
DRUG	Beta-Adrenergic Antagonist	Receive beta-blocker regimen as per SOC
DRUG	Propranolol	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Resistance Training	Undergo strength training for 6 months
OTHER	Short-Term Fasting	Participate in intermittent fasting

Timeline

• Start date: 2022-06-28
• Primary completion: 2027-06-28
• Completion: 2027-06-28
• First posted: 2022-04-05
• Last updated: 2025-12-01

Locations

1 site across 1 country: United States