Multiple Myeloma (MM)MFMNCT07236502
Moving Forward With Myeloma: A Lifestyle Intervention for Individuals With Multiple Myeloma
A study testing Immediate intervention and Waitlist in people with Multiple Myeloma (MM), run by Medical College of Wisconsin at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM)
- What is being tested?
- Immediate intervention and Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jan 2026to 28 Feb 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥ 18 years)
- Diagnosed with MM at least one year prior to study enrollment
- 100 days post transplant (if applicable)
- Has access to a smart phone or device with internet access
- Be deemed "clinically stable" by their physician guided by the following:
- not expected to receive therapies beyond maintenance (for 100 days)
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- no new significant myeloma symptoms (e.g., fractures, spinal stability concerns) meriting changes in anti-neoplastic therapies in the next 30 days; AND
- stable performance status (ECOG 0-2) assessed in the last 3 months
- 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 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
Who cannot join
- Coexistent amyloidosis, POEMS syndrome will not be approached
- Fully adherent to the ACS nutrition and physical activity guidelines
- If participant is of child-bearing age they cannot be pregnant, planning to come pregnant or lactating during the study period
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Loyola University Chicago
Maywood, Illinois, 60153
Patricia Sheean, PhD, 464-220-9216, psheean1@luc.edu
Paula O'Connor, 464-220-9912, poconnor1@luc.edu
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Melinda Stolley, PhD, 414-955-7533, mstolley@mcw.edu
Moriah Mitchell, 414-955-2377, momitchell@mcw.edu
About this study
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.
- In-person assessment to measure physical function, height/weight, body composition, and includes a blood draw
- Surveys completed online or on paper at home
Read the 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.
- Conditions
- Multiple Myeloma (MM)
- Being tested
- Immediate intervention, Waitlist
- Keywords
- Lifestyle Intervention
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate interventionBehavioural
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
WaitlistOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Immediate intervention; Other: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.)
Measured: Baseline, Week 16, Week 32, Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start30 Jan 2026
- Primary completion15 Dec 2029 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Waitlist Control
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Loyola University Chicago
- Responsible party
- Principal investigator, Melinda Stolley, Medical College of Wisconsin
- Investigators
- Melinda Stolley, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236502
- Sponsor's protocol ID
- PRO00040708
- Other IDs
- 1R01CA300310
- Acronym
- MFM
- Status last verified
- Jul 2026
- First submitted
- 6 Nov 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data on participant characteristics and outcomes will be shared.