NCT06987708

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

Evaluating the Impact of a 12-month Multi-Modal Lifestyle Management Intervention on Disease Relevant Biomarkers Associated With Monoclonal Gammopathy of Unknown Significance (MGUS) and Smoldering Myeloma (SM): A Prospective Intervention Pilot Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Hackensack Meridian Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients with a diagnosis of MGUS or SM who are willing and able to participate in this 12-month multimodal lifestyle approach. Eligible patients include those 18 years of age and older diagnosed with MGUS/SM, ECOG PS 0-2, absence of significant comorbidities, and ability to speak/read/understand English. The multimodal lifestyle intervention has six foci: Positive cognition \[mindset\], Exercise/movement, Stress Reduction, Social Connection, Emotional Wellbeing, and Nutrition. All programming will take place online to maximize convenience/sustained participation.

Conditions

• Monoclonal Gammopathy of Uncertain Significance
• Smoldering Myeloma

Interventions

Type	Name	Description
OTHER	The Multimodal Lifestyle Intervention	The multimodal lifestyle intervention has six foci: positive cognition, exercise/movement, stress reduction, social connection, emotional well-being, and nutrition

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2025-05-23
• Last updated: 2026-03-23