Lifestyle and Supportive Care for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen by Jens Hillengass, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Approved in 3 Jurisdictions

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.

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.

What data supports the effectiveness of the drug propranolol for multiple myeloma?

Research shows that propranolol, a drug commonly used for high blood pressure, may help treat multiple myeloma by slowing cancer cell growth and increasing cell death. A study found that patients with multiple myeloma who used propranolol had better survival rates compared to those who did not use it. ^{1 2 3 4 5}

Is propranolol generally safe for humans?

Propranolol, a medication used for over 50 years to treat high blood pressure, has been shown to have some serious and non-serious side effects, including bradycardia (slow heart rate). However, it is generally considered safe when used as prescribed. ^{1 2 3 4 6}

How is the drug Propranolol unique in treating multiple myeloma?

Propranolol is unique in treating multiple myeloma because it is primarily a beta-blocker used for heart conditions, and its use in this context may focus on supportive care aspects, such as managing stress or heart-related side effects, rather than directly targeting the cancer itself. ^{7 8 9 10 11}

Research Team

Jens Hillengass, MD, PhD

Principal Investigator

Roswell Park Cancer Institute

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

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 am 18 years old or older.

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.

Trial Timeline

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

Treatment Details

Interventions

• Behavioral Intervention (Behavioral Intervention)
• Propranolol (Beta-Adrenergic Antagonist)
• Quality-of-Life Assessment (Other)
• Questionnaire Administration (Other)
• Resistance Training (Behavioral Intervention)
• Short-Term Fasting (Other)

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.

Participant Groups

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 Canada for the following indications:

Approved in Canada as Propranolol for:

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Roswell Park Cancer Institute Buffalo, NY

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Patients Recruited

40,500+

Findings from Research

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

New indication for therapeutic potential of an old well-known drug (propranolol) for multiple myeloma. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Beta-blockers improve survival outcomes in patients with multiple myeloma: a retrospective evaluation. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Comparative pharmacokinetic and pharmacodynamic study of four different brands of propranolol in normal volunteers. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of a chronotherapeutically administered beta blocker vs. a traditionally administered beta blocker in patients with hypertension. [2021]

6. India pubmed.ncbi.nlm.nih.gov

Therapeutic class-specific signal detection of bradycardia associated with propranolol hydrochloride. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Supportive Care in Multiple Myeloma. [2020]

8. England pubmed.ncbi.nlm.nih.gov

The pharmacologic management of multiple myeloma in older adults. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Survivorship care guidelines for patients living with multiple myeloma: consensus statements of the International Myeloma Foundation Nurse Leadership Board. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Supportive therapy in multiple myeloma. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

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