Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-03-13 @ 11:24 AM
Study NCT ID:
NCT07236502
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Moving Foward With Myeloma (MFM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014850', 'term': 'Waiting Lists'}], 'ancestors': [{'id': 'D001071', 'term': 'Appointments and Schedules'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Waitlist Control'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 184}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-11-06', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Inflammation', 'timeFrame': 'Baseline, Week 16, Week 32, Week 48', 'description': 'Examine the associations between lifestyle behaviors and serum biomarkers for inflammation. Markers of inflammation including CRP, IL-6; TNF-alpha will be analyzed (blind to randomization) in batch at the end of data collection using commercially available ELISA kits. Each sample will be assayed in duplicate and repeated if variability exceeds 15%.'}, {'measure': 'Biological Aging', 'timeFrame': 'Baseline, Week 16, Week 32', 'description': 'o Biological Aging/Cellular Senescence. Additional blood samples will be collected in PAXgene RNA (2.5 mL) tubes and stored (-80° C). Cellular senescence will be assessed via transcript abundance of the p16INK4a- and p21-encoding genes (CDKN2A and CDKN1A, respectively).23-25 A priori-defined sets of genes known to be up-regulated during the DNA damage response (DDR; 30 genes; e.g., CHEK1, SIRT1, TP53, TERF2), and the senescence-associated secretory phenotype (SASP; 61 genes; e.g., IL1A, IL13, CXCL8, CSF2, VEGF) will also be assessed.'}], 'primaryOutcomes': [{'measure': 'Examine the efficacy of the intervention in producing post-intervention changes in performance-based physical function', 'timeFrame': 'Baseline, Week 16, Week 32, Week 48', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Examine the efficacy of the intervention in producing post-intervention changes in patient-reported outcomes.', 'timeFrame': 'Baseline, Week 16, Week 32, Week 48', 'description': '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.'}, {'measure': '• Godin Leisure Physical Activity:', 'timeFrame': 'Baseline, Week 16, Week 32, Week 48', 'description': 'A tool querying about light, moderate, strenuous activities over 7-days and one item asking about strength training'}, {'measure': '• ASA 24-hour Dietary Recall (DR).', 'timeFrame': 'Baseline, Week 16, Week 32, Week 48', 'description': "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."}, {'measure': '• Self-Efficacy for Eating and Exercise Behaviors:', 'timeFrame': 'Baseline, Week 16, Week 32, Week 48', 'description': 'A validated tool consisting of 12 items to assess exercise self-efficacy and 20 items to assess healthy eating and exercise self-efficacy'}, {'measure': 'Fruit and Vegetable Intake - objective measure', 'timeFrame': 'Baseline, Week 16, Week 32, Week 48', 'description': '• 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.'}, {'measure': 'Outcome Expectancy.', 'timeFrame': 'Baseline, Week 16, Week 32, Week 48', 'description': '• 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.'}, {'measure': 'Resilience', 'timeFrame': 'Baseline, Week 16, Week 32, Week 48', 'description': "• 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"}, {'measure': 'Body composition', 'timeFrame': 'Baseline, Week 16, Week 32, Week 48', 'description': '• 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)'}, {'measure': 'Objective Physical Activity. (ActivPal):', 'timeFrame': 'Baseline, Week 16, Week 32, Week 48', 'description': '• 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.'}, {'measure': 'Lipids and Glucose', 'timeFrame': 'Baseline, Week 16, Week 32, Week 48', 'description': '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.)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lifestyle Intervention'], 'conditions': ['Multiple Myeloma (MM)']}, 'descriptionModule': {'briefSummary': '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:\n\nDo 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.\n\n1. In-person assessment to measure physical function, height/weight, body composition, and includes a blood draw\n2. Surveys completed online or on paper at home', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult (≥ 18 years)\n2. Diagnosed with MM at least one year prior to study enrollment\n3. Has access to a cell phone\n4. Be deemed "clinically stable" by their physician guided by the following:\n\n 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)\n 2. no new significant myeloma symptoms (e.g., fractures) meriting changes in anti-neoplastic therapies; AND\n 3. stable performance status (ECOG 0-2)\n5. 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)\\].\n6. Able to participate in moderate PA and strength training per clinician approval and confirmed by participant\n7. Able to understand and willing to sign a written informed consent document\n8. English proficient for reading and writing\n\nExclusion Criteria:\n\n1. Individuals with \\<6 months of life anticipated, coexistent amyloidosis, and/or receiving appetite stimulants will not be approached\n2. Fully adherent to the ACS nutrition and physical activity guidelines\n3. Currently pregnant or lactating, or anticipating pregnancy\n4. On another interventional clinical trial that precludes co-enrollment\n5. Psychiatric or other clinical conditions that preclude study compliance\n6. Other important medical or safety considerations at the discretion of the investigator(s) and/or approving clinician'}, 'identificationModule': {'nctId': 'NCT07236502', 'acronym': 'MFM', 'briefTitle': 'Moving Foward With Myeloma (MFM)', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Moving Forward With Myeloma: A Lifestyle Intervention for Individuals With Multiple Myeloma', 'orgStudyIdInfo': {'id': 'PRO00040708'}, 'secondaryIdInfos': [{'id': '1R01CA300310', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA300310', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate Intervention', '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.', 'interventionNames': ['Behavioral: Immediate intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Waitlist control', '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.', 'interventionNames': ['Behavioral: Immediate intervention', 'Other: Waitlist']}], 'interventions': [{'name': 'Immediate intervention', 'type': 'BEHAVIORAL', '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', 'armGroupLabels': ['Immediate Intervention', 'Waitlist control']}, {'name': 'Waitlist', 'type': 'OTHER', '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', 'armGroupLabels': ['Waitlist control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'contacts': [{'name': 'Patricia Sheean, PhD', 'role': 'CONTACT', 'email': 'psheean1@luc.edu', 'phone': '464-220-9216'}, {'name': 'Patricia Sheean, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Loyola University Chicago', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'contacts': [{'name': 'Melinda Stolley, PhD', 'role': 'CONTACT', 'email': 'mstolley@mcw.edu', 'phone': '414-955-7533'}], 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Melinda Stolley, PhD', 'role': 'CONTACT', 'email': 'mstolley@mcw.edu', 'phone': '(312)735-6044'}], 'overallOfficials': [{'name': 'Melinda Stolley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Once the study is completed, de-identified data collected during the study will be made available.', 'ipdSharing': 'YES', 'description': 'De-identified data on participant characteristics and outcomes will be shared.', 'accessCriteria': '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Loyola University Chicago', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Melinda Stolley', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}