Moving Foward With Myeloma (MFM)

NCT07236502 | Not Yet Recruiting DMC

• 2 other identifiers: PRO000407081R01CA300310
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Multiple Myeloma (MM)

Keywords

Lifestyle Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

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

  Baseline, Week 16, Week 32, Week 48

• • Godin Leisure Physical Activity:

  Baseline, Week 16, Week 32, Week 48

• • ASA 24-hour Dietary Recall (DR).

  Baseline, Week 16, Week 32, Week 48

• • Self-Efficacy for Eating and Exercise Behaviors:

  Baseline, Week 16, Week 32, Week 48

• Fruit and Vegetable Intake - objective measure

  Baseline, Week 16, Week 32, Week 48

Other Outcomes (2)

• Inflammation

  Baseline, Week 16, Week 32, Week 48

• Biological Aging

  Baseline, Week 16, Week 32

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

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

Waitlist control

ACTIVE COMPARATOR

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; Other: Waitlist

Interventions

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

Immediate Intervention; Waitlist control

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

Waitlist control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• National Cancer Institute (NCI): collaborator
• Loyola University Chicago: collaborator

Study Sites (2)

Loyola University Chicago

Maywood, Illinois, 60153, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Melinda Stolley, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melinda Stolley, PhD

CONTACT

(312)735-6044; mstolley@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Waitlist Control

Study Record Dates

• First Submitted: November 6, 2025
• First Posted: November 19, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): December 15, 2029
• Study Completion (Estimated): February 28, 2030
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Once the study is completed, de-identified data collected during the study will be made available.
• 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

Locations

US (2)