A prospective, pilot study to assess the impact of a 12-month multi-focal lifestyle intervention on myeloma-relevant biomarkers in patients with MGUS or SM. The multimodal lifestyle intervention has six foci that patients will participate in over the course of one-year.
Adults 18 years or older.
Diagnosed with MGUS or SM based on commonly accepted criteria per the
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
Ability to speak, read and comprehend the English language.
60% or greater clonal plasma cells on bone marrow examination
Serum involved / uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved light chain is at least 100mg/L (a patient's involved free light chain either kappa or lambda is the one that is above the normal reference range; the uninvolved free light chain is the one that is typically in, or below, the normal range)
More than one focal lesion on MRI that is at least 5mm or greater in size.
Hypercalcemia: serum calcium >0.25 mmol/L (>1mg/dL) higher than the upper limit of normal or >2.75 mmol/L (>11mg/dL)
Single group
The Multimodal Lifestyle Intervention
Other interventionThe multimodal lifestyle intervention has six foci: positive cognition, exercise/movement, stress reduction, social connection, emotional well-being, and nutrition
Efficacy of multi-modal lifestyle intervention based on any of the 3 specified myeloma tumor burden biomarker surrogates
Efficacy of the multi-modal lifestyle intervention will be based on measurements of 3 myeloma-relevant biomarkers: M-Spike Protein, Free kappa light chains, and Free lambda-light chains. We will first determine which monoclonal protein is dominant for a given patient based on his/her/their individual lab values. These labs will be taken at baseline and compared to levels at 4-, 8-, and 12-month intervals to assess for changes in protein levels.
Patient Acceptability (engagement) of the Lifestyle Intervention
Patient acceptability will be measured by a patient acceptability questionnaire
Patient Adherence (compliance) to the Lifestyle Intervention
Patient adherence will be measured based on attendance at clinic visits, the various scheduled individual and group meetings across all intervention components, and via the use of wearable technology
Correlation between specified inflammation biomarkers and any of the 3 specified myeloma tumor burden biomarker surrogates
Inflammation will be measured using 3 surrogate markers: IL-6, TNF-alpha, and VEGF. These labs will be taken at baseline and compared to levels at 4-, 8-, and 12-month intervals to assess for a reduction in these levels and any observed correlation with myeloma markers
Correlation between patient glucose levels/changes and any of the 3 specified myeloma tumor burden biomarker surrogates
Fasting insulin levels and hemoglobin A1c (HbA1c) measurements will be taken at baseline and compared to levels at 4-, 8-, and 12-month intervals to assess for improvements and any observed correlation with designated myeloma markers. Average of In-Range Continuous Glucose Monitor (CGM) recordings will be calculated at baseline and compared to levels at 4-, 8-, and 12-month intervals to assess for improvements and correlation with select myeloma biomarkers.
Correlation between lipid-related biomarkers/changes and any of the 3 specified myeloma tumor burden biomarker surrogates
Body mass index (BMI), Abdominal Visceral Fat; High Density Lipoprotein - Cholesterol (HDL-C), Apolipoprotein A-1(APO A1), and Adiponectin will be measured at baseline and compared to levels at 4-, 8-, and 12-month intervals to assess for improvements and any correlation with the identified myeloma biomarkers
Validation of the PESSEN questionnaire
The PESSEN Questionnaire (Positive cognition, Emotional wellbeing, Social connection, Stress reduction, Exercise, Nutrition) is designed to assess a patient's overall lifestyle wellness as measured across six areas, assess the degree to which a patient believes that these six areas of lifestyle interventions can improve their cancer outcome, and to assign them a lifestyle wellness score.
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Hackensack Meridian Health
Lead sponsor
Center for Cancer Lifestyle Management
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
