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NCT07236502
Moving Forward With Myeloma: A Lifestyle Intervention for Individuals With Multiple Myeloma
Conditions: Multiple Myeloma (MM)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 184
Sponsor: Medical College of Wisconsin
Location: Loyola University Chicago Maywood Illinois
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
Eligibility Criteria
Inclusion Criteria:
1. Adult (≥ 18 years)
2. Diagnosed with MM at least one year prior to study enrollment
3. 100 days post transplant (if applicable)
4. Has access to a smart phone or device with internet access
5. Be deemed "clinically stable" by their physician guided by the following:
1. not expected to receive therapies beyond maintenance (for 100 days)
2. no new significant myeloma symptoms (e.g., fractures, spinal stability concerns) meriting changes in anti-neoplastic therapies in the next 30 days; AND
3. stable performance status (ECOG 0-2) assessed in the last 3 months
6. No reports of severe pain \> Grade 3 \[defined by the NCI CTCAE as tumor, neurologic, bone, or other pain interfering with self-care ADLs (bathing, dressing, toileting, continence, feeding)\].
7. Able to participate in PA and strength training per clinician approval and confirmed by participant
8. Able to understand and willing to sign a written informed consent document
9. English proficient for reading and writing
Exclusion Criteria:
1. Coexistent amyloidosis, POEMS syndrome will not be approached
2. Fully adherent to the ACS nutrition and physical activity guidelines
3. If participant is of child-bearing age they cannot be pregnant, planning to come pregnant or lactating during the study period
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
Source: ClinicalTrials.gov (NCT07236502). StuddyBuddy aggregates publicly available trial information.