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Beta-Adrenergic Antagonist

Lifestyle and Supportive Care for Multiple Myeloma

N/A

Recruiting

Led By Jens Hillengass

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

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

MODULE A (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and at 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating the effect of adding physical activity, nutritional intervention, and beta blockers to the standard treatment for multiple myeloma. The goal is to improve patient survival outcomes and quality of life.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical reactions to increased physical activity or dietary changes such as muscle soreness or digestive discomfort. Propranolol could cause low blood pressure, slow heartbeat, fatigue, dizziness among other symptoms; however individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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I have been diagnosed with smoldering multiple myeloma or multiple myeloma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious health issues that could worsen by joining this study.

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

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My BMI is below 18, indicating malnutrition.

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I have been diagnosed with acute bone instability by a CT scan.

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I am diabetic and take medication or insulin to manage it.

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I do not have conditions that prevent me from using beta-blockers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in immune cell subsets

Secondary study objectives

Change in functional status

Changes in anxiety

Changes in body composition

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Propranolol

2010

Completed Phase 4

~1290

Behavioral Intervention

2021