Non-Chemotherapy Approaches for Multiple Myeloma and Immune Function
This study is looking at ways to improve quality of life and immune function for people with multiple myeloma (a type of blood cancer) or smoldering multiple myeloma (a pre-cancerous condition). Researchers are testing different approaches that don't involve chemotherapy. These include wearing a FitBit device to encourage physical activity, following an intermittent fasting plan, and taking a beta-blocker called propranolol. The study aims to see how these interventions affect immune cells and overall well-being. You may be able to join if you are 18 or older and have been diagnosed with multiple myeloma, smoldering multiple myeloma, or plasma cell leukemia. The study is currently unclear about its recruitment status.
- Study design
- This interventional study plans to enroll 175 participants. It is not specified if it is randomized or blinded.
- What's involved
- Depending on the group you are in, you might participate in supervised strength training for 6 months, wear a FitBit device for 6 months, or follow an intermittent fasting plan for 1 month. You will also have quality-of-life assessments and questionnaires.
- Compensation
- Not stated in the trial record.
- Follow-up
- Changes in immune cell subsets will be measured at the beginning of the study and again at 1 year.
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NCT05312255
Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma
Recruiting
NAAges 18+InterventionalTreatmentRoswell Park Cancer InstituteInvestigator-initiated
~175 participants
Updated 2025-12-01 on ClinicalTrials.gov
What's tested:Behavioral InterventionBeta-Adrenergic AntagonistPropranololQuality-of-Life AssessmentQuestionnaire AdministrationResistance Training
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in immune cell subsets
Measured over At baseline and at 1 year
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Jens Hillengass · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Changes in immune cell subsetsAt baseline and at 1 year
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).