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NCT Number: NCT07236502

Moving Forward With Myeloma: A Lifestyle Intervention for Individuals With Multiple Myeloma

The purpose of this project is to evaluate the impact of a 16-week lifestyle program that promotes changes in eating and exercise patterns. The main questions the study will answer are:

Do improvements in eating and exercise patterns lead to improved physical function, quality of life and blood biomarkers of biologial aging among individuals with multiple myeloma? Participants will complete study activities 3-4 times during the study.

1. In-person assessment to measure physical function, height/weight, body composition, and includes a blood draw 2. Surveys completed online or on paper at home

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loyola University Chicago, Maywood, Illinois, United States

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About this study

The study uses a randomized, waitlist control design. Following baseline data collection, participants will be randomized to either the immediate lifestyle intervention group or the waitlist control group. Those who are randomized to the waitlist control group will receive the intervention after the 16-week data collection time point.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (≥ 18 years)
  • Diagnosed with MM at least one year prior to study enrollment
  • Has access to a cell phone
  • Be deemed "clinically stable" by their physician guided by the following:
  • no near-term changes in planned myeloma-directed therapy anticipated. (e.g., patient who is 3 months from autologous stem cell transplant just starting on maintenance lenalidomide is eligible since maintenance is planned therapy following transplant)
  • no new significant myeloma symptoms (e.g., fractures) meriting changes in anti-neoplastic therapies; AND
  • stable performance status (ECOG 0-2)
  • No reports of severe pain > Grade 3 [defined by the NCI CTCAE as tumor, neurologic, bone, or other pain interfering with self-care ADLs (bathing, dressing, toileting, continence, feeding)].
  • Able to participate in moderate PA and strength training per clinician approval and confirmed by participant
  • Able to understand and willing to sign a written informed consent document
  • English proficient for reading and writing

Exclusion criteria

  • Individuals with <6 months of life anticipated, coexistent amyloidosis, and/or receiving appetite stimulants will not be approached
  • Fully adherent to the ACS nutrition and physical activity guidelines
  • Currently pregnant or lactating, or anticipating pregnancy
  • On another interventional clinical trial that precludes co-enrollment
  • Psychiatric or other clinical conditions that preclude study compliance
  • Other important medical or safety considerations at the discretion of the investigator(s) and/or approving clinician

Treatment and study plan

Immediate intervention

Behavioral

16-session intervention that facilitates changes in nutrition and physical activity behaviors to promote improvements in physical function, Patient Reported Outcomes, body composition and general health

Waitlist

Other

Participants will be asked to maintain their behavior over the 16 week waitlist period and will receive weekly text message relating positive messages unrelated to lifestyle

Primary outcomes

  1. Examine the efficacy of the intervention in producing post-intervention changes in performance-based physical function

    Time frame: Baseline, Week 16, Week 32, Week 48

    Changes in performance-based physical function between the interventional and control groups will be measured using the Short Physical Performance Battery (SPPB), which comprises a 4-meter walk test to assess gait speed, sit-to-stand test to assess lower body strength, and standing balance tests to assess balance. Scoring for the SPPB ranges from 0 to 12; higher scores indicate higher function.

Secondary outcomes

  1. Examine the efficacy of the intervention in producing post-intervention changes in patient-reported outcomes.

    Time frame: Baseline, Week 16, Week 32, Week 48

    Changes in patient-reported outcomes between the interventional and control groups will be measured using: the Patient Reported Outcomes Measurement Information System (PROMIS) physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, pain intensity, satisfaction with social roles and activities, instrumental support, informational support, emotional support, companionship, cognitive function and social isolation. The PROMIS measures for this study will be used in a CAT Computer adaptive format.

  2. • Godin Leisure Physical Activity:

    Time frame: Baseline, Week 16, Week 32, Week 48

    A tool querying about light, moderate, strenuous activities over 7-days and one item asking about strength training

  3. • ASA 24-hour Dietary Recall (DR).

    Time frame: Baseline, Week 16, Week 32, Week 48

    Supported by the National Cancer Institute's ASA24 and with administrative assistance, a minimum of 2 unannounced 24DR will be completed pre/post-intervention using the 5-pass dietary recall methodology.

  4. • Self-Efficacy for Eating and Exercise Behaviors:

    Time frame: Baseline, Week 16, Week 32, Week 48

    A validated tool consisting of 12 items to assess exercise self-efficacy and 20 items to assess healthy eating and exercise self-efficacy

  5. Fruit and Vegetable Intake - objective measure

    Time frame: Baseline, Week 16, Week 32, Week 48

    • Veggie meter- Participants will be asked to complete reflective spectroscopy using the Veggie Meter; a device that non-invasively measures the level of carotenoid pigments in the skin.
  6. Outcome Expectancy.

    Time frame: Baseline, Week 16, Week 32, Week 48

    • Measures positive and negative outcome expectations ("I would sleep more soundly if I exercised regularly"; "Regular exercise would increase my pain.") Higher scores indicate greater positive or negative outcome expectations.
  7. Resilience

    Time frame: Baseline, Week 16, Week 32, Week 48

    • The Brief Resilience Scale (BRS) is a psychological measure designed to quantify a person's ability to 'bounce back' or recover from stressful events or trauma
  8. Body composition

    Time frame: Baseline, Week 16, Week 32, Week 48

    • DEXA imaging is a 10-minute, noninvasive technique that provides precise whole-body measures of fat (total and visceral) and lean mass. Certified DXA technologists will perform and analyze whole body measures using the same machine for each participant at each time point)
  9. Objective Physical Activity. (ActivPal):

    Time frame: Baseline, Week 16, Week 32, Week 48

    • Participants wear this device on the right thigh, held on by a Tegaderm patch to measure PA and sedentary time. Data are downloaded using ActiLife software and will be analyzed using recommended thresholds for moderate and vigorous PA.
  10. Lipids and Glucose

    Time frame: Baseline, Week 16, Week 32, Week 48

    Utilizing clinical resources at MCW or LUC phlebotomy will be performed by trained personnel to conduct fasting blood draws and blood processing according to standard procedures. Whole blood will be collected, allowed to clot for 20 mins, and centrifuged at 2,500 rpm for 20 mins. o Lipids (HDL, LDL, Total Cholesterol, Triglycerides) and glucose measures will be procured using the Choletech LDX (Abbott, Inc.)

Other outcomes

  1. Inflammation

    Time frame: Baseline, Week 16, Week 32, Week 48

    Examine the associations between lifestyle behaviors and serum biomarkers for inflammation. Markers of inflammation including CRP, IL-6; TNF-alpha will be analyzed (blind to randomization) in batch at the end of data collection using commercially available ELISA kits. Each sample will be assayed in duplicate and repeated if variability exceeds 15%.

  2. Biological Aging

    Time frame: Baseline, Week 16, Week 32

    o Biological Aging/Cellular Senescence. Additional blood samples will be collected in PAXgene RNA (2.5 mL) tubes and stored (-80° C). Cellular senescence will be assessed via transcript abundance of the p16INK4a- and p21-encoding genes (CDKN2A and CDKN1A, respectively).23-25 A priori-defined sets of genes known to be up-regulated during the DNA damage response (DDR; 30 genes; e.g., CHEK1, SIRT1, TP53, TERF2), and the senescence-associated secretory phenotype (SASP; 61 genes; e.g., IL1A, IL13, CXCL8, CSF2, VEGF) will also be assessed.

Study contacts

Contact information is provided by the study sponsor or research team.

Melinda Stolley, PhD

CONTACT

[email protected]

(312)735-6044

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Loyola University Chicago
  • National Cancer Institute (NCI)

Registry information

Acronym: MFM

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Nov 19, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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