Lifestyle and Supportive Care for Multiple Myeloma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Must not be taking: Beta blockers, Calcium channel blockers

Disqualifiers: Cardiac diseases, Pulmonary diseases, Diabetes, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1-6 months

175 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how lifestyle changes and the medication propranolol (a beta-blocker) might improve life for people with multiple myeloma, a type of blood cancer, or a related condition called MDS. Researchers aim to determine if exercise, diet changes, and propranolol can boost the immune system and enhance overall well-being. The trial includes different groups: one for exercise, one for intermittent fasting, and one where propranolol is added to standard care. It suits people newly diagnosed with multiple myeloma who need treatment and aren't currently on a beta-blocker. As an unphased trial, this study offers a unique opportunity to explore innovative lifestyle and treatment combinations that could enhance quality of life.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but if you are currently using a beta-blocker, you must stop at least 3 months before enrolling in Module C. If you are on a special diet or taking glucose-lowering medications, you may not be eligible for Module B.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that strength training is generally safe for people with multiple myeloma. Research indicates it can strengthen bones, reduce tiredness, and ease pain, especially for those with a low risk of fractures.

Exercise programs are also considered safe and can improve the overall quality of life for people with multiple myeloma by reducing fatigue and boosting mental well-being.

Intermittent fasting looks promising but lacks specific data for multiple myeloma. Early findings suggest it is safe and might improve the quality of life for cancer patients.

Propranolol, a medication used for other conditions, has been studied in multiple myeloma patients. Research shows it might be safe and could help improve survival. Some studies suggest it has anti-cancer effects, but more research is needed to fully understand its safety in this context.

Overall, these non-chemotherapy treatments are generally well-tolerated and may improve life quality for patients. However, individual experiences can vary, and discussing any concerns with a healthcare provider is best. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for multiple myeloma because they explore how lifestyle changes and supportive therapies can enhance patient care. Unlike traditional treatments that focus solely on medication, this approach includes strength training, intermittent fasting, and the use of propranolol. Strength training and behavioral interventions aim to improve physical fitness and increase daily activity through remote sessions with a trainer and digital prompts. Intermittent fasting offers a novel dietary approach that could potentially improve health outcomes. Propranolol, a beta-blocker, is being investigated for its potential benefits beyond heart disease, adding a new dimension to supportive care in multiple myeloma.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Research has shown that strength training, one of the interventions in this trial, can significantly reduce pain and fatigue while enhancing the quality of life for people with multiple myeloma. Studies have found that exercise can also boost physical abilities and mental well-being. Participants in this trial may also undergo intermittent fasting, which early findings suggest can improve quality of life and may offer cancer-related benefits. Another arm of this trial involves propranolol; studies indicate it can improve survival rates for multiple myeloma patients, likely by slowing cancer cell growth. Overall, these non-chemotherapy methods being tested in this trial may help reduce symptoms and improve life quality for patients. ^{3 6 7 8 9}

Who Is on the Research Team?

Jens Hillengass, MD, PhD

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

Adults with smoldering multiple myeloma or multiple myeloma who can follow study procedures and have no major comorbidities posing a risk. Participants must consent to the study, use contraception if of child-bearing potential, and meet specific performance status criteria. Exclusions include serious health conditions like heart disease, infections, psychiatric issues that affect compliance, certain dietary restrictions for nutrition module participants, current beta-blocker users or those with contraindications to beta-blockers.

Inclusion Criteria

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

I have just been diagnosed with multiple myeloma and have not started treatment.

I can care for myself and perform daily activities with little to no difficulty.

Exclusion Criteria

MODULE B (NUTRITION): Special diets (physician prescribed)

I have a current broken bone or severe muscle system instability that causes symptoms.

My BMI is below 18, indicating malnutrition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo various non-chemotherapeutic interventions including strength training, intermittent fasting, and beta-blocker therapy

1-6 months

Remote and in-person visits as per module requirements

Follow-up

Participants are monitored for changes in immune markers, nutritional behavior, stress-related biomarkers, and other health parameters

3-12 months

Follow-up visits every 3 months for up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Intervention
• Propranolol
• Quality-of-Life Assessment
• Questionnaire Administration
• Resistance Training
• Short-Term Fasting

Trial Overview

The trial is testing non-chemotherapeutic interventions such as physical activity (with necessary equipment), nutritional changes including short-term fasting (excluding diabetics on medication), and the addition of propranolol—a beta-adrenergic antagonist—to standard treatment in newly diagnosed patients before systemic therapy starts. The goal is to see how these interventions impact immune function and quality of life.

How Is the Trial Designed?

Group I: Module D Experimental Treatment 2 Interventions

MDS Patients undergo strength training for 6 months.

Group II: Module C Group I (propranolol) Experimental Treatment 3 Interventions

Patients receive propranolol PO BID for 3 months.

Group III: Module B (intermittent fasting) Experimental Treatment 3 Interventions

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.

Group IV: Module A (strength training, behavioral intervention) Experimental Treatment 4 Interventions

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.

Group V: Module C Group II (propranolol) Active Control 3 Interventions

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

Propranolol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Inderal for:

• High blood pressure
• Angina pectoris
• Heart rhythm disorders
• Migraine prophylaxis
• Essential tremor
• Performance anxiety

Approved in European Union as Propranolol for:

• Hypertension
• Angina pectoris
• Arrhythmias
• Migraine prophylaxis
• Essential tremor
• Anxiety

Approved in Canada as Propranolol for:

• Hypertension
• Angina pectoris
• Arrhythmias
• Migraine prophylaxis
• Essential tremor
• Anxiety

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Published Research Related to This Trial

A study involving 44 hypertensive patients showed that a new delayed-release beta blocker formulation (INP) taken at night resulted in greater reductions in blood pressure and heart rate during the early morning hours compared to the traditional morning dose (ILA).

In beta-blocker sensitive patients, the delayed-release formulation led to a more significant decrease in cardiac workload, as indicated by a greater reduction in the double product (a measure of myocardial oxygen demand) during the critical morning period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a chronotherapeutically administered beta blocker vs. a traditionally administered beta blocker in patients with hypertension. Neutel, JM., Rotenberg, K.[2021]

In a study of 1,971 newly diagnosed multiple myeloma patients, those who used beta-blockers (BB) showed significantly improved disease-specific survival (DSS) compared to patients who did not use any cardiac medications, with a hazard ratio of 0.53, indicating a 47% reduced risk of disease-specific death.

Patients using beta-blockers alone or in combination with other cardiac drugs also demonstrated better overall survival (OS) rates compared to those on non-beta-blocker cardiac medications, suggesting that beta-blockers may positively influence survival outcomes in multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beta-blockers improve survival outcomes in patients with multiple myeloma: a retrospective evaluation. Hwa, YL., Shi, Q., Kumar, SK., et al.[2022]

The role of pharmacists in managing multiple myeloma has become crucial as advancements in treatment have turned it into a chronic disease, with pharmacists providing essential counseling on new therapies and supportive care for patients.

The pharmacist-led 'Virtual Multiple Myeloma Clinic' has been effective in optimizing patient care by offering personalized monitoring and support for patients on oral immunomodulatory therapies, highlighting the importance of pharmacists in the healthcare team.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary Professional Roles Addressing Needs in Multiple Myeloma: An Innovative 'Virtual' Pharmacist Surveillance Clinic. Ebied, M., Chan, V.[2021]

Recent therapies for multiple myeloma have significantly improved overall survival rates for both newly diagnosed and relapsed patients, highlighting the effectiveness of these treatments.

The International Myeloma Foundation Nurse Leadership Board has identified key patient needs, such as bone health and mobility, and created a survivorship care plan to help manage these issues effectively throughout the patient's care journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship care guidelines for patients living with multiple myeloma: consensus statements of the International Myeloma Foundation Nurse Leadership Board. Bilotti, E., Faiman, BM., Richards, TA., et al.[2021]

The chapter provides an overview of supportive measures that can help prevent complications associated with multiple myeloma, enhancing patient safety during treatment.

These measures aim to improve patient wellbeing while undergoing specific anti-myeloma therapies, highlighting the importance of comprehensive care in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive therapy in multiple myeloma. Ludwig, H., Zojer, N.[2018]

Older adults with multiple myeloma face unique challenges in treatment due to their increased susceptibility to chemotherapy-related toxicities and pre-existing health conditions, making careful management essential.

Despite these challenges, intensive therapies like autologous hematopoietic cell transplant (AHCT) should still be considered for older patients, as advancements in treatment options and multi-drug regimens can improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacologic management of multiple myeloma in older adults. Dempsey, JL., Johns, A., Rosko, AE., et al.[2023]

The study analyzed data from the Canadian Adverse Drug Reaction Monitoring Program to assess the potential link between propranolol hydrochloride and bradycardia, finding that the signals for bradycardia were not statistically significant despite some high calculated statistics.

Although the results did not confirm a strong association between propranolol and bradycardia, the authors suggest that further investigation using larger databases is warranted due to the observed trends.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic class-specific signal detection of bradycardia associated with propranolol hydrochloride. Gavali, DK., Kulkarni, KS., Kumar, A., et al.[2021]

A study involving six healthy adult volunteers tested four different brands of propranolol (Inderal, Ciplar, Corbeta, and Propal) to assess variations in how the body absorbs and responds to the medication.

The results showed no significant differences in the pharmacokinetic (how the drug is processed in the body) and pharmacodynamic (the drug's effects on the body) parameters among the brands, indicating they are likely interchangeable in terms of efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative pharmacokinetic and pharmacodynamic study of four different brands of propranolol in normal volunteers. Biswas, NR., Garg, SK., Kumar, N., et al.[2013]

Propranolol demonstrates significant antiproliferative and apoptotic effects on multiple myeloma cells, with IC50 values decreasing over time (141 μM at 24 hours to 75 μM at 72 hours), indicating its potential as a treatment option.

The mechanism of action involves increased caspase-3 activity and changes in gene expression related to apoptosis, including upregulation of pro-apoptotic factors and downregulation of Bcl-2, suggesting a targeted approach to inducing cell death in cancer cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New indication for therapeutic potential of an old well-known drug (propranolol) for multiple myeloma. Kozanoglu, I., Yandim, MK., Cincin, ZB., et al.[2021]

Long-acting propranolol (Inderal LA) provides a controlled release of the medication, maintaining higher plasma concentrations over 24 hours compared to conventional tablets, which helps ensure consistent beta-adrenoceptor blockade.

This formulation is equally effective for treating conditions like angina pectoris, hypertension, and hyperthyroidism, while potentially improving patient adherence to treatment due to simplified dosing regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-acting propranolol (Inderal LA): pharmacokinetics, pharmacodynamics and therapeutic use. Mishriki, AA., Weidler, DJ.[2019]

Recent studies have shown that high-cutoff hemodialysis can effectively remove free light chains in patients with renal disease related to multiple myeloma, improving their kidney function.

Updated guidelines recommend the use of levofloxacin to prevent infections and suggest effective management strategies for bone disease and anemia, which are crucial for enhancing the quality of life in myeloma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive Care in Multiple Myeloma. Guzdar, A., Costello, C.[2020]

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