Moving Foward With Myeloma (MFM)

Medical College of Wisconsin

Status: Not yet enrolling

Conditions: Multiple Myeloma (MM)

Treatments: Behavioral: Immediate intervention; Other: Waitlist

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07236502

1R01CA300310 (U.S. NIH Grant/Contract)

PRO00040708

Details and patient eligibility

About

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

Full 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.

Enrollment: 184 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

184 participants in 2 patient groups

Immediate Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Immediate intervention

Waitlist control

Active Comparator group

Description:

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.

Treatment:

Other: Waitlist

Behavioral: Immediate intervention