Moving Foward With Myeloma (MFM) (MFM)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Myeloma (MM)
• Intervention / Treatment: Behavioral: Immediate intervention; Other: Waitlist

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 184
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melinda Stolley, PhD; Phone Number: (312)735-6044; Email: mstolley@mcw.edu

Study Locations

• United States
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Chicago
      • Contact: Patricia Sheean, PhD; Phone Number: 464-220-9216; Email: psheean1@luc.edu
      • Principal Investigator: Patricia Sheean, PhD
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
      • Contact: Melinda Stolley, PhD; Phone Number: 414-955-7533; Email: mstolley@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult (≥ 18 years)
2. Diagnosed with MM at least one year prior to study enrollment
3. Has access to a cell phone

4. Be deemed "clinically stable" by their physician guided by the following:

   1. 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)
   2. no new significant myeloma symptoms (e.g., fractures) meriting changes in anti-neoplastic therapies; AND
   3. stable performance status (ECOG 0-2)
5. 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)].
6. Able to participate in moderate PA and strength training per clinician approval and confirmed by participant
7. Able to understand and willing to sign a written informed consent document
8. English proficient for reading and writing

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Intervention; 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. The intervention targets plant-based eating, increasing physical activity and strength training.	Behavioral: Immediate intervention; 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
Active Comparator: Waitlist control; 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.	Behavioral: Immediate intervention; 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; Other: Waitlist; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examine the efficacy of the intervention in producing post-intervention changes in performance-based physical function	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.	Baseline, Week 16, Week 32, Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examine the efficacy of the intervention in producing post-intervention changes in patient-reported outcomes.	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.	Baseline, Week 16, Week 32, Week 48
• Godin Leisure Physical Activity:	A tool querying about light, moderate, strenuous activities over 7-days and one item asking about strength training	Baseline, Week 16, Week 32, Week 48
• ASA 24-hour Dietary Recall (DR).	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.	Baseline, Week 16, Week 32, Week 48
• Self-Efficacy for Eating and Exercise Behaviors:	A validated tool consisting of 12 items to assess exercise self-efficacy and 20 items to assess healthy eating and exercise self-efficacy	Baseline, Week 16, Week 32, Week 48
Fruit and Vegetable Intake - objective measure	• 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.	Baseline, Week 16, Week 32, Week 48
Outcome Expectancy.	• 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.	Baseline, Week 16, Week 32, Week 48
Resilience	• 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	Baseline, Week 16, Week 32, Week 48
Body composition	• 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)	Baseline, Week 16, Week 32, Week 48
Objective Physical Activity. (ActivPal):	• 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.	Baseline, Week 16, Week 32, Week 48
Lipids and Glucose	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.)	Baseline, Week 16, Week 32, Week 48

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation	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%.	Baseline, Week 16, Week 32, Week 48
Biological Aging	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.	Baseline, Week 16, Week 32

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: National Cancer Institute (NCI); Loyola University Chicago
• Investigators: Principal Investigator: Melinda Stolley, PhD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2026
• Primary Completion (Estimated): December 15, 2029
• Study Completion (Estimated): February 28, 2030

Study Registration Dates

• First Submitted: November 6, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Estimated): November 19, 2025

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Lifestyle Intervention
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Organization and Administration; Health Services Administration; Appointments and Schedules; Waiting Lists
• Other Study ID Numbers: PRO00040708; 1R01CA300310 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data on participant characteristics and outcomes will be shared.
• IPD Sharing Time Frame: Once the study is completed, de-identified data collected during the study will be made available.
• IPD Sharing Access Criteria: Once the study is completed, de-identified data collected during the study will be deposited in the Harvard Dataverse. Raw RNA-seq, alignment, and transcript data will be made available to the research community free of charge through GEO. Since the purpose of this data sharing is to answer questions in the future, your
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No