Improving quality of life and immune function in multiple myeloma patients through lifestyle changes
Improving Host Factors in Patients With Monoclonal Gammopathies and Other Hematologic Disorders
This study is testing whether lifestyle changes like exercise and diet can improve the immune system and quality of life for people with multiple myeloma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 175 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT05312255 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of non-chemotherapeutic interventions, such as physical activity and dietary modifications, on the immune function and quality of life of patients with multiple myeloma. Participants will engage in various modules, including supervised strength training, intermittent fasting, and the addition of a beta-blocker to their treatment regimen. The study aims to assess how these interventions impact immune markers, bone turnover, mental health, and overall well-being. The trial will utilize remote access for training and monitoring to ensure patient engagement and adherence.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of multiple myeloma or related hematologic disorders and an ECOG performance status of 0-2.
Not a fit: Patients with significant comorbidities, severe myeloma symptoms, or treatment side effects that could jeopardize their safety during the study may not benefit.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life and immune response in patients with multiple myeloma, potentially leading to better treatment outcomes.
How similar studies have performed: Previous studies, such as those conducted at the Mayo Clinic, have shown promising results with similar non-chemotherapeutic approaches in improving outcomes for multiple myeloma patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Buffalo, New York
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jens Hillengass — Roswell Park Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.