About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- The Multimodal Lifestyle Intervention
Treatment groups
Locations
Sponsors and collaborators
Hackensack Meridian Health
Lead sponsor
Center for Cancer Lifestyle Management
Collaborator