Recruiting

Lifestyle Program

Sponsor:

Medical College of Wisconsin

Code:

NCT07236502

Conditions

Multiple Myeloma (MM)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Immediate intervention

Waitlist

Study Details

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. 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

Conditions

Multiple Myeloma (MM)

Study ID

NCT07236502

Start date

Jan 30, 2026

Status verified date

Jul, 2026

Completion date

Feb 28, 2030

Anticipated

Primary completion date

Dec 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

184 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Melinda Stolley, PhD

(312)735-6044mstolley@mcw.edu

Locations

Loyola University Chicago

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Patricia Sheean, PhD

464-220-9216psheean1@luc.edu

Principal Investigator:

Patricia Sheean, PhD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Melinda Stolley, PhD

414-955-7533mstolley@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Lifestyle Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-07-22.