Health Through Activity Program for Multiple Myeloma

Overseen By Kathleen Lyons, ScD, OTR/L

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MGH Institute of Health Professions

Disqualifiers: Bone pain, Fracture, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a structured exercise program, the Health Through Activity (HTA) program, can improve physical function and quality of life for people with multiple myeloma. Participants will engage in a six-session rehabilitation exercise plan designed to promote physical activity and participation in meaningful activities. It suits individuals with multiple myeloma who are on maintenance therapy and experience health issues that disrupt daily activities. The trial excludes those with severe bone pain, recent fractures, or conditions that make exercise unsafe. As an unphased trial, this study provides an opportunity to explore innovative methods to enhance well-being and daily functioning.

Do I have to stop taking my current medications for the trial?

The trial does not specify whether you need to stop taking your current medications. However, since participants must be currently receiving maintenance therapy for multiple myeloma, it seems likely that you can continue your existing treatment.

What prior data suggests that the Health Through Activity program is safe for participants with multiple myeloma?

Research shows that exercise programs for people with multiple myeloma are generally safe. Participants have not reported serious side effects, and only a few minor issues have arisen. Studies have also shown that exercise is safe for those at low risk of bone fractures. People with multiple myeloma can exercise safely at any stage of their treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Health Through Activity (HTA) intervention for multiple myeloma because it focuses on improving patients' quality of life through increased physical activity, rather than traditional medical treatments like chemotherapy or stem cell transplants. Unlike standard treatments that target the cancer directly, this program aims to enhance overall well-being and potentially improve health outcomes by encouraging regular exercise and monitoring its effects. By integrating a personalized approach with active participation and feedback, HTA could provide valuable insights into how lifestyle modifications can complement existing therapies and improve life quality for those living with multiple myeloma.

What evidence suggests that the Health Through Activity program is effective for improving physical functioning and quality of life in multiple myeloma patients?

Research shows that exercise programs like the Health Through Activity (HTA) intervention, which participants in this trial will undergo, can benefit people with multiple myeloma. Studies have found that the most active individuals often experience improvements in blood counts and quality of life. Exercise programs for multiple myeloma patients are generally safe, with no serious side effects reported. Although only a small number of patients currently follow exercise recommendations, those who do often experience positive results. Overall, participating in a structured exercise program can enhance physical function and overall well-being for multiple myeloma patients. ^{1 3 6 7 8}

Who Is on the Research Team?

Kathleen Lyons, ScD, OTR/L

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with multiple myeloma who are on maintenance therapy and find their daily or social activities limited by health problems. It's not suitable for those with new or uncontrolled bone pain, recent fractures without repair, conditions preventing safe exercise, or moderate to severe cognitive impairment.

Inclusion Criteria

I am currently on maintenance therapy for multiple myeloma.

My health issues prevent me from doing daily or social activities.

Exclusion Criteria

I had a bone break in the last year that didn't need surgery.

I have new or worsening bone pain that greatly affects my daily life.

I don't have any health issues that prevent me from safely exercising.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 months

Treatment

Participants undergo the Health Through Activity (HTA) program, which includes a six-session rehabilitation exercise regimen

6 weeks

6 weekly visits (in-person)

Follow-up

Participants complete a Satisfaction survey and an individual, semi-structured interview to provide feedback about the program

Up to 4 months

What Are the Treatments Tested in This Trial?

Interventions

• Health Through Activity (HTA)

Trial Overview The study tests the 'Health Through Activity' program, which includes a six-session rehabilitation exercise regimen designed to improve physical function and quality of life in people living with multiple myeloma.

How Is the Trial Designed?

Group I: Health Through Activity (HTA) Intervention Experimental Treatment 1 Intervention

Participants will undergo study procedures as outlined: * Complete a baseline survey regarding activity level and quality of life. * Attend 6 weekly study visits at the MGH Institute of Health Professions IMPACT Practice Center. * Attend final study visit and complete the Satisfaction survey and an individual, semi-structured interview with site staff to supply feedback about the program. * After six weeks, complete the Satisfaction survey again.

Who Is Running the Clinical Trial?

MGH Institute of Health Professions

Lead Sponsor

Trials

19

Recruited

2,200+

Published Research Related to This Trial

A survey of 34 clinical haematologists revealed that while 97% recognize the importance of physical activity (PA) for multiple myeloma patients, many lack confidence in providing specific exercise recommendations or identifying resources.

Despite acknowledging the benefits of PA for quality of life and mental health, 44% of haematologists do not refer patients to exercise professionals, indicating a need for better support and clearer referral pathways to enhance patient access to exercise guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting exercise for patients with multiple myeloma: attitudes and practices of clinical haematologists. Nicol, JL., Hill, MM., Burton, NW., et al.[2022]

Exercise programs for people with multiple myeloma (MM) are safe, with no serious adverse events reported and high attendance rates (58% to 96%) across seven studies involving 563 participants.

While exercise did not significantly improve fatigue, depression, or quality of life, it did show some benefits in physical performance measures, such as increased lower limb strength and peak oxygen uptake, suggesting potential for enhancing physical health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Feasibility, and Efficacy of Exercise Interventions for People With Multiple Myeloma: A Systematic Review. Nicol, JL., Chong, JE., McQuilten, ZK., et al.[2023]

This trial will assess the impact of a 12-week exercise intervention on health-related quality of life (HRQoL) in 60 patients with multiple myeloma, a cancer known for causing significant bone pain and lesions.

The study will also evaluate secondary outcomes such as bone health, fatigue, and muscle strength, aiming to determine if exercise should be integrated into standard care for improving overall health in multiple myeloma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Individualized Exercise Intervention for People with Multiple Myeloma-Study Protocol of a Randomized Waitlist-Controlled Trial. Nicol, JL., Woodrow, C., Cunningham, BJ., et al.[2022]

Only 12% of people with multiple myeloma (MM) remained physically active after treatment, highlighting a significant drop in activity levels post-diagnosis, especially among those who were not active before their diagnosis.

The study found that 55% of respondents expressed interest in low-cost, flexible exercise programs supervised by specialists, indicating a need for accessible physical activity options to help improve their health and manage symptoms during and after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity in People with Multiple Myeloma: Associated Factors and Exercise Program Preferences. Nicol, JL., Woodrow, C., Burton, NW., et al.[2020]

Patients with multiple myeloma generally believe that exercise is beneficial and would recommend it to others undergoing similar treatments, indicating a positive perception of exercise as part of their care.

The study highlights that patients' adherence to exercise programs during aggressive treatment is influenced by their personal beliefs and social contexts, suggesting that clinicians should consider these factors to enhance patient engagement in exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Keep moving: patients with myeloma talk about exercise and fatigue. Coon, SK., Coleman, EA.[2006]

A randomized trial involving 187 patients with newly diagnosed multiple myeloma found that a home-based individualized exercise program (HBIEP) did not significantly reduce fatigue, improve sleep, or enhance aerobic performance compared to usual care over a 15-week period.

Despite the minimal impact on fatigue and performance, the study suggests that exercise is safe for patients undergoing treatment for multiple myeloma and may provide physiological benefits, particularly in alleviating anemia when combined with epoetin alfa therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise on fatigue, sleep, and performance: a randomized trial. Coleman, EA., Goodwin, JA., Kennedy, R., et al.[2021]

A study involving 30 multiple myeloma patients showed that exercise therapy is safe and feasible, with no adverse events reported during the program.

Among those who adhered to the exercise regimen, significant improvements in physical functioning and a trend towards reduced fatigue were observed, suggesting that exercise may enhance quality of life for MM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical exercise therapy program with multiple myeloma patients: Impacts on feasibility, adherence and efficacy. Wefelnberg, MM., Niels, T., Holtick, U., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10062531/

Physical Activity in Multiple Myeloma: A Review of the ... Compared with the control groups, the most active participants show better outcomes, such as improvements in their blood counts and in quality- ...

2. withpower.com withpower.com/trial/phase-neoplasms-plasma-cell-1-2023-7c36f

Health Through Activity Program for Multiple Myeloma Research shows that exercise programs for people with multiple myeloma are generally safe, with no serious adverse events reported and only a few minor issues.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7601964/

Physical Activity in People with Multiple Myeloma This study explored PA among people with MM, including differences by treatment stage, symptoms and demographics, and programming preferences.

4. academic.oup.com academic.oup.com/oncolo/article/29/10/e1336/7704467

Physical activity and exercise motivation of multiple myeloma ... Our study of 211 consecutive MM patients revealed that 17% of them fulfilled the WHO exercising recommendations. While patients were more active ...

5. valueinhealthjournal.com valueinhealthjournal.com/article/S1098-3015(23)04970-7/pdf

HTA156 Health Technology Assessment of Multiple ... Results: Of the 125 reimbursement recommendations from both HTA agencies, 11.2% were based on phase 2 trials only and 65.6% were based on phase 3 trials only, ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2152265022017116

Safety, Feasibility, and Efficacy of Exercise Interventions for ... Exercise is safe for people with multiple myeloma at low risk of pathological fracture. Participation in exercise programs is feasible for people with multiple ...

7. bmcsportsscimedrehabil.biomedcentral.com bmcsportsscimedrehabil.biomedcentral.com/articles/10.1186/s13102-025-01193-4

Exercise interventions in patients with multiple myeloma For patients with MM, exercise interventions are considered safe, feasible, and effective. The research results indicate that exercise ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04484714

NCT04484714 | Virtual Exercise for Multiple Myeloma The main objective of this study is to determine the safety and feasibility of a 12-week virtually supported home-based aerobic and resistance exercise program ...