Trial Summary
What is the purpose of this trial?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.
What data supports the idea that Lifestyle and Supportive Care for Multiple Myeloma is an effective treatment?The available research shows that propranolol, a drug often used for heart conditions, may help people with multiple myeloma. Studies found that patients using propranolol had better survival rates compared to those who didn't use it. This suggests that propranolol could be a helpful part of supportive care for multiple myeloma.12378
Is the drug Propranolol a promising treatment for multiple myeloma?The provided research articles focus on supportive care and management strategies for multiple myeloma, but they do not mention Propranolol as a promising treatment for this condition. Therefore, based on the available information, we cannot conclude that Propranolol is a promising treatment for multiple myeloma.5691011
What safety data exists for the treatment in the clinical trial?The safety data for propranolol, a component of the treatment, includes its long history of use as a beta-blocker for hypertension, with known serious and non-serious adverse events such as bradycardia. Studies have shown its potential therapeutic effects in multiple myeloma, including improved survival outcomes. However, specific safety data for other components like lifestyle interventions, resistance training, and fasting are not detailed in the provided research.12478
Do I need to stop my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are currently using a beta-blocker, you must stop at least 3 months before enrolling in Module C of the trial. Please consult with your doctor for more details.
Eligibility Criteria
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
I am 18 years old or older.
I can care for myself and perform daily activities with little to no difficulty.
I have been diagnosed with smoldering multiple myeloma or multiple myeloma.
Exclusion Criteria
I do not have serious health issues that could worsen by joining this study.
I have a current broken bone or severe muscle system instability that causes symptoms.
My BMI is below 18, indicating malnutrition.
I have been diagnosed with acute bone instability by a CT scan.
I am diabetic and take medication or insulin to manage it.
I do not have conditions that prevent me from using beta-blockers.
Treatment Details
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.
5Treatment groups
Experimental Treatment
Active Control
Group I: Module DExperimental Treatment2 Interventions
MDS Patients undergo strength training for 6 months.
Group II: Module C Group I (propranolol)Experimental Treatment3 Interventions
Patients receive propranolol PO BID for 3 months.
Group III: Module B (intermittent fasting)Experimental Treatment3 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 Treatment4 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 Control3 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Roswell Park Cancer InstituteBuffalo, NY
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Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
References
Comparative pharmacokinetic and pharmacodynamic study of four different brands of propranolol in normal volunteers. [2013]The pharmacokinetic and pharmacodynamic studies of four different brands of propranolol (Inderal, Ciplar, Corbeta and Propal) were carried out after single and multiple dosing on six normal adult healthy volunteers in a randomized crossover fashion to determine any inter-brand variations in bioavailability and pharmacodynamic effects. No significant difference was observed in any of the pharmacokinetic and pharmacodynamic parameters of four different brands of propranolol studied.
Long-acting propranolol (Inderal LA): pharmacokinetics, pharmacodynamics and therapeutic use. [2019]Long-acting propranolol (Inderal LA) is a new formulation of propranolol that allows release of the drug in a controlled manner, so that the plasma concentration at 24 hr after dosing is greater with long-acting propranolol than with conventional tablets. A single dose of 160 mg of long-acting propranolol can produce cardiac beta-adrenoceptor blockade throughout a 24 hr period without variability due to multiple peak concentrations. It has been shown that this formulation is as effective in the treatment of angina pectoris, hypertension and hyperthyroidism as the standard formulation. Studies with long-acting propranolol in cardiac dysrhythmias are lacking. This new dosage form would be a means of simplifying dosing regimens and thereby hopefully enhancing patient convenience and compliance.
Comparison of a chronotherapeutically administered beta blocker vs. a traditionally administered beta blocker in patients with hypertension. [2021]Increasing systolic blood pressure and heart rate during the early morning results in increased myocardial oxygen demand. The use of beta blockers during this period may decrease cardiac workload, particularly in beta-blocker sensitive patients. The impact of a new chronotherapeutic beta blocker was assessed in 44 hypertensive patients. Patients were randomized to delayed-release propranolol (INP) dosed at 10 p.m. or to traditionally dosed propranolol (ILA) dosed at 8 a.m. for 4 weeks, following which they were switched to the alternative formulation for 4 weeks. Thirty-four-hour ambulatory blood pressure monitoring and pharmacokinetic measurements were obtained. INP and ILA resulted in significant reductions in mean 24-hour blood pressure (-9.0/-6.9 mm Hg and -10.4/-7.7 mm Hg, respectively). The top 25% of responders to high-dose propranolol (sensitive patients) were compared on each formulation. Mean trough reductions were -8.0/-6.7 mm Hg and -7.6/-5.8 mm Hg, respectively. Mean blood pressure reductions in the beta-blocker sensitive patients (n = 11) between 6 a.m. and noon were -15.2/-11.9 mm Hg on INP and -8.0/-4.6 mm Hg on ILA. Heart rate reduction was -14.1 bpm and double product reduction was -3319 in the INP patients between 6 a.m. and 12 noon compared with -10.5 and -2209 in the ILA patients. This study suggests that INP and ILA are effective once-a-day beta blockers, but the use of delayed-release propanolol results in a greater reduction in double product between 6 a.m. and noon in beta-blocker sensitive patients than does traditionally dosed propranolol.
Therapeutic class-specific signal detection of bradycardia associated with propranolol hydrochloride. [2021]Propranolol hydrochloride, one of the most widely used beta-blocker in the treatment of hypertension since 1960s, shows a number of serious and non-serious adverse events.
Supportive therapy in multiple myeloma. [2018]In this chapter we want to give an overview on various supportive measures, which help to prevent or to fight complications of multiple myeloma, improve patient wellbeing and increase safety of administration of specific anti-myeloma therapy.
Survivorship care guidelines for patients living with multiple myeloma: consensus statements of the International Myeloma Foundation Nurse Leadership Board. [2021]Novel therapies approved over the past decade for the management of multiple myeloma have contributed to improved overall survival in patients with newly diagnosed and relapsed disease. Nurses play a key role in educating, advocating for, and supporting patients throughout the continuum of care. Identifying potential and actual comorbid conditions associated directly with multiple myeloma and its treatment is important, as is confirming those that are patient specific so that prompt intervention can take place; therefore, the International Myeloma Foundation Nurse Leadership Board identified the most significant needs of patients diagnosed with multiple myeloma as bone health, health maintenance, mobility and safety, sexual dysfunction, and renal health. The Nurse Leadership Board then developed a survivorship care plan to assist healthcare providers and patients with multiple myeloma, their partners, and their caregivers to identify these needs.
New indication for therapeutic potential of an old well-known drug (propranolol) for multiple myeloma. [2021]Propranolol, a non-selective β-adrenergic receptor blocker, has been used for the treatment of the patients with hypertension for more than 50 years. There are several in vitro and in vivo evidences that β-adrenergic receptor antagonists inhibit proliferation and angiogenesis and also increase apoptosis in breast, skin, and colon cancers. The aim of this study was to investigate the cytotoxic and apoptotic effects of propranolol and the genes involved in propranolol-induced apoptosis in multiple myeloma cells.
Beta-blockers improve survival outcomes in patients with multiple myeloma: a retrospective evaluation. [2022]A preclinical study demonstrated anti-proliferative and apoptotic effect of propranolol on multiple myeloma (MM) cell. Clinical studies suggested that beta-blocker (BB) might impact the prognosis of breast, prostate, colorectal, ovarian, lung, and skin cancer. This retrospective study evaluated the effect of BB in MM disease-specific survival (DSS) and overall survival (OS). Among 1,971 newly diagnosed MM patients seen at Mayo Clinic between 1995 and 2010, usage of BB and other cardiac (or antihypertensive) medications were abstracted. Cumulative incidence function and Kaplan-Meier method were used to estimate 5-year cumulative incidence rate (CIR) of MM death and OS rate, respectively. Nine hundred and thirty (47.2%) patients had no intake of cardiac medications; 260 (13.2%) used BB alone; 343 (17.4%) used both BB/non-BB cardiac medications; and 438 (22.2%) had non-BB cardiac drugs. Superior MM DSS was observed in BB only users, compared to patients without any cardiac drugs ( HRadj.CS, 0.53, 95% confidence interval [CI], 0.42-0.67, Padj. <0.0001) and non-BB cardiac drugs users ( HRadj.CS, 0.49, 95% CI, 0.38-0.63, Padj. <0.0001). Patients on both BB and other cardiac drugs showed superior DSS than non-cardiac drugs users ( HRadj.CS, 0.54, 95% CI, 0.44-0.67, Padj. <0.0001) and non-BB cardiac drug users. ( HRadj.CS, 0.50, 95% CI, 0.40-0.62, Padj. <0.0001). MM DSS did not differ between BB users with and without other cardiac drugs (Padj. =0.90). Multivariable analysis showed the same pattern for OS. In patients with MM, BB intake is associated with a reduced risk of disease-specific death and overall mortality in comparison to non-BB or no use of cardiac drugs. Am. J. Hematol. 92:50-55, 2017. © 2016 Wiley Periodicals, Inc.
The pharmacologic management of multiple myeloma in older adults. [2023]Multiple myeloma is a disease predominately affecting older adults. Pivotal to treating older adults is understanding their physiologic differences compared to younger subjects and how the complexity of therapies has an impact upon this patient population.
Supportive Care in Multiple Myeloma. [2020]As novel therapies are expanding the life expectancy of patients with multiple myeloma, appropriate supportive care has become critical in the management of these patients. This review aims to outline the key principles of supportive care of patients with myeloma, including management of bone disease, renal disease, anemia, peripheral neuropathy, infections, and venous thromboembolism.
Multidisciplinary Professional Roles Addressing Needs in Multiple Myeloma: An Innovative 'Virtual' Pharmacist Surveillance Clinic. [2021]Advances in pharmacologic options has rendered multiple myeloma a chronic disease for most patients. This article explores the role of the pharmacist in new therapy start counseling, supportive care, and patient navigation in people affected by multiple myeloma. The role of the pharmacist in the pharmacist-led 'Virtual Multiple Myeloma Clinic' and the foundations guiding pharmacist prescribing are described in detail. Directions for future patient-centered research and opportunities in multiple myeloma are explored, specific to this jurisdiction.