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

NCT05312255 | Recruiting DMC

• 2 other identifiers: I 1680221NCI-2022-01918
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plasma Cell Myeloma; Recurrent Plasma Cell Myeloma; Refractory Plasma Cell Myeloma; Smoldering Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (1)

• Changes in immune cell subsets

  Will be assessed by flow cytometry, comparing levels before and after one of three lifestyle interventions (physical exercise, intermittent fasting, beta blocker therapy). Will use a linear mixed model. Since the form of the model is unknown a priori, the power calculations are based on comparing any two timepoints using a two-sided paired t-test. With n=100, we have 80% power (at alpha = 0.05/3) to detect a difference of at least 0.33 standard deviations (SD).

  At baseline and at 1 year

Secondary Outcomes (9)

• Changes in the gut microbiome

  At 1 and 3 months

• Comparison in bone markers

  At 1 and 3 months

• Changes in body composition

  3 months

• Changes in stress

  At 1 and 3 months

• Changes in anxiety

  At 1 and 3 months

Study Arms (5)

Module A (strength training, behavioral intervention)

EXPERIMENTAL

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.

Behavioral: Behavioral Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Resistance Training

Module B (intermittent fasting)

EXPERIMENTAL

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.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Short-Term Fasting

Module C Group I (propranolol)

EXPERIMENTAL

Patients receive propranolol PO BID for 3 months.

Drug: Propranolol; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Module C Group II (propranolol)

ACTIVE COMPARATOR

Patients continue receiving beta-blocker regimen as per SOC for 3 months.

Drug: Beta-Adrenergic Antagonist; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Module D

EXPERIMENTAL

MDS Patients undergo strength training for 6 months.

Behavioral: Behavioral Intervention; Other: Resistance Training

Interventions

Behavioral Intervention BEHAVIORAL

Wear a FitBit device and receive prompts for 6 months

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Module A (strength training, behavioral intervention); Module D

Beta-Adrenergic Antagonist DRUG

Receive beta-blocker regimen as per SOC

Also known as: Beta Blocker, Beta-Adrenergic Blocking Agent, Beta-Blockers

Module C Group II (propranolol)

Propranolol DRUG

Given PO

Also known as: 1-[(1-Methylethyl)amino]-3-(1-naphthalenyloxy)-2-propanol

Module C Group I (propranolol)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Module A (strength training, behavioral intervention); Module B (intermittent fasting); Module C Group I (propranolol); Module C Group II (propranolol)

Questionnaire Administration OTHER

Ancillary studies

Module A (strength training, behavioral intervention); Module B (intermittent fasting); Module C Group I (propranolol); Module C Group II (propranolol)

Resistance Training OTHER

Undergo strength training for 6 months

Also known as: Strength Training

Module A (strength training, behavioral intervention); Module D

Short-Term Fasting OTHER

Participate in intermittent fasting

Also known as: Intermittent Fasting, Short-term Intermittent Fasting

Module B (intermittent fasting)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years of age
• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of:
• Module A: ECOG 0 - 1
• Module B: ECOG 0 - 2
• Module C: ECOG 0 - 2
• Module D: ECOG 0-1
• MODULE A, B and C: Have a diagnosis of smoldering multiple myeloma, multiple myeloma or plasma cell leukemia (PCL) or
• MODULE D: non transfusion dependent low-risk MDS
• Show no signs of comorbidities, myeloma symptoms, or treatment side effects that would put them in danger when participating in the study according to the physician's discretion
• Are able to understand and follow assessment and intervention procedures
• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
• MODULE A and D (PHYSICAL ACTIVITY): Participant has access to a personal computer or tablet with camera, microphone, speakers and internet access
• MODULE B (NUTRITION): Not applicable
• MODULE C (BETA BLOCKER): Newly diagnosed patients with multiple myeloma necessitating treatment and before initiation of systemic therapy
• MODULE C: Female participants of child-bearing potential must have a negative pregnancy test at study entry and then agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Male patients with female partners of child-bearing potential should also use adequate contraceptive methods (see above). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately MODULE D: Patients with MDS not necessitating transfusion therapy at time of enrollment (no transfusion within 8 weeks prior to enrollment) i.e. patients on observation, or receiving growth factors or luspatercept only

You may not qualify if:

• Major comorbidities that would cause danger to the patient when participating in the study and that would have a risk of progression if the patient took part in the study (including, but not limited to): cardiac or pulmonary and infectious diseases (e.g., ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) or, psychiatric illness/social situations that would limit compliance with study requirements
• Unwilling or unable to follow protocol requirements
• Any condition which in the investigator's opinion deems the participant an unsuitable candidate to take part in study intervention (comorbidities, myeloma symptoms, treatment side effects)
• MODULE A (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system that is deemed to making the patient unsafe to participate. This will be assessed by radiologist, a neurosurgeon and/or an orthopedic surgeon, if applicable.
• MODULE A (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system
• MODULE A (PHYSICAL ACTIVITY): Acute bone instability as assessed by whole body low-dose computed tomography and evaluated by an experienced surgeon
• MODULE B (NUTRITION): Clinical signs of malnutrition (body mass index \[BMI\] \< 18)
• MODULE B (NUTRITION): Special diets (physician prescribed)
• MODULE B (NUTRITION): Diabetic treated with glucose-lowering medications and/or insulin
• MODULE B (NUTRITION): Other reasons not to withhold food
• MODULE B (NUTRITION): Any condition which in the investigator's opinion deems the participant an unsuitable candidate to limit food consumption
• MODULE C (BETA BLOCKER): Current use of a beta blocker (includes all non-selective and beta-1 selective blockers) or, use of a beta-blocker within 3 months of study enrollment
• MODULE C (BETA BLOCKER): Contraindications to the use of beta-blockers, e.g.; severe sinus bradycardia; sick sinus syndrome; or heart block greater than first-degree, uncontrolled depression, unstable angina pectoris, uncontrolled heart failure (New York Heart Association \[NYHA\] Grade III or IV), hypotension ( systolic blood pressure \< 100 mmHg), severe asthma or chronic obstructive pulmonary disease (COPD), uncontrolled type I or type II diabetes mellitus (HbA1C \> 8.5 or 12h fasting plasma glucose \> 160 mg/dL at screening), symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma, current calcium channel blocker use (Non-dihydropyridines such as verapamil) or rhythm control agents such as digoxin and amiodarone. Patients with pacemakers will be excluded
• MODULE C (BETA BLOCKER): Pregnant or nursing female participants, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
• MODULE D: Cardiovascular disease which is deemed limiting exercise readiness by a cardiologist

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Smoldering Multiple Myeloma

Interventions

Behavior Therapy; Adrenergic beta-Antagonists; Propranolol; Resistance Training

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Precancerous Conditions; Hypergammaglobulinemia

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jens Hillengass

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 5, 2022
• Study Start: June 28, 2022
• Primary Completion (Estimated): June 28, 2027
• Study Completion (Estimated): June 28, 2027
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

US (1)