Actively Recruiting
Improving Host Factors in Patients With Monoclonal Gammopathies and Other Hematologic Disorders
Led by Roswell Park Cancer Institute · Updated on 2025-12-01
175
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how non-chemotherapy interventions affect patients with multiple myeloma or myelodysplastic syndrome (MDS). This study explores the impact of physical activity, nutritional changes, and the addition of the beta-blocker propranolol to standard treatment on immune function and quality of life. Previous observations suggest beta-blockers might improve survival for multiple myeloma patients during chemotherapy, so this study aims to further understand these effects in newly diagnosed patients. Participants are assigned to different modules based on their condition and treatment status. Module A involves twice-weekly strength training via internet supervision and wearing a FitBit for 6 months. Module B includes intermittent fasting with an 8-hour eating window daily for 1 month. Module C compares two groups: one receives propranolol twice daily for 3 months, and the other continues their standard beta-blocker regimen for 3 months. Module D, for patients with low-risk MDS, offers resistance training twice weekly for 6 months. Follow-up visits occur after the interventions, varying from 3 months to 1 year depending on the module. During the study, participants undergo assessments of immune cells, bone markers, body composition, stress levels, anxiety, fatigue, and physical function at multiple time points. Researchers also analyze changes in the gut microbiome and nutritional behaviors. Data is collected through devices, questionnaires, and laboratory tests. The primary outcome is immune cell changes measured at baseline and after one year. Participants' health and safety are monitored throughout, with study durations ranging from 1 to 6 months for interventions plus follow-up periods.
CONDITIONS
Brief Title
Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 for Modules A and D, 0-2 for Modules B and C
- Diagnosis of smoldering multiple myeloma, multiple myeloma, or plasma cell leukemia for Modules A, B, and C
- Diagnosis of non-transfusion-dependent low-risk myelodysplastic syndrome for Module D
- No comorbidities, myeloma symptoms, or treatment side effects that pose danger as determined by physician
- Ability to understand and follow assessment and intervention procedures
- Signed informed consent
- Access to a personal computer or tablet with camera, microphone, speakers, and internet for Modules A and D
- Newly diagnosed multiple myeloma patients requiring treatment before systemic therapy initiation for Module C
- Female participants of child-bearing potential must have negative pregnancy test and agree to use adequate contraception; male participants with female partners of child-bearing potential must use contraception
You will not qualify if you...
- Major comorbidities posing danger during study, including cardiac, pulmonary, infectious diseases, psychiatric illness, or social situations limiting study compliance
- Unwillingness or inability to follow protocol requirements
- Investigator-determined unsuitability due to comorbidities, myeloma symptoms, or treatment side effects
- For Module A: current symptomatic pathological fractures or severe musculoskeletal instability
- For Module A: acute bone instability as assessed by imaging and surgeon evaluation
- For Module B: clinical signs of malnutrition (BMI below 18), special physician-prescribed diets, diabetes treated with glucose-lowering medications or insulin, or conditions unsuitable for food restriction
- For Module C: current or recent beta-blocker use within 3 months
- For Module C: contraindications to beta-blockers including severe bradycardia, heart block, uncontrolled depression, unstable angina, uncontrolled heart failure (NYHA III or IV), hypotension, severe asthma or COPD, uncontrolled diabetes, symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma, current use of certain calcium channel blockers or rhythm control agents, and presence of pacemaker
- For Module C: pregnancy or nursing females
- For Module D: cardiovascular disease limiting exercise readiness as judged by cardiologist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 6 months depending on assigned module
Participants undergo assigned interventions including strength training, intermittent fasting, or beta-blocker medication depending on their module assignment.
Twice weekly sessions for 6 months for strength training; 1 month of intermittent fasting; daily propranolol for 3 months
Duration - Up to 1 year depending on module
Participants are followed after completion of their assigned intervention to assess long-term effects on immune function, quality of life, and other health measures.
Every 3 months for 1 year for Module A; visits at 3 and 5 months for Module B; 3 months for Module C
Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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