Recruiting

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

Sponsor:

Roswell Park Cancer Institute

Code:

NCT05312255

Conditions

Plasma Cell Myeloma

Recurrent Plasma Cell Myeloma

Refractory Plasma Cell Myeloma

Smoldering Plasma Cell Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Behavioral Intervention

Beta-Adrenergic Antagonist

Propranolol

Quality-of-Life Assessment

Questionnaire Administration

Study Details

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

Study ID

NCT05312255

Start date

Jun 28, 2022

Status verified date

Nov, 2025

Completion date

Jun 28, 2027

Anticipated

Primary completion date

Jun 28, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

175 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Module A (strength training, behavioral intervention)

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.

experimental: Module B (intermittent fasting)

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.

experimental: Module C Group I (propranolol)

Patients receive propranolol PO BID for 3 months.

active comparator: Module C Group II (propranolol)

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

experimental: Module D

MDS Patients undergo strength training for 6 months.

Interventions

Behavioral Intervention

Wear a FitBit device and receive prompts for 6 months

Beta-Adrenergic Antagonist

Receive beta-blocker regimen as per SOC

Propranolol

Given PO

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Resistance Training

Undergo strength training for 6 months

Short-Term Fasting

Participate in intermittent fasting

Primary outcome measure

Changes in immune cell subsets [ Time Frame: At baseline and at 1 year ]

Central Contacts and Locations

Locations

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Jens Hillengass

716-845-3863 jens.hillengass@roswellpark.org

Principal Investigator:

Jens Hillengass

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Dec 1, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2025-12-01.