Evaluating the Impact of a 12-month Multi-Modal Lifestyle Management Intervention on Disease Relevant Biomarkers

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHackensack Meridian Health

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

67 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Hackensack Meridian Health

Lead sponsor

Center for Cancer Lifestyle Management

Collaborator