Actively Recruiting
Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies
Led by M.D. Anderson Cancer Center · Updated on 2026-04-15
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand the quality of life and related anxiety in patients with monoclonal gammopathy of unknown significance (MGUS) and smoldering multiple myeloma (SMM). By collecting quality of life information, the study seeks to identify common symptoms and patient concerns to help guide future treatments or preventive measures. Participants are patients already enrolled in clinical trials at MD Anderson Cancer Center. Participants complete quality of life questionnaires either every six months if in an observational study or monthly if in a treatment study, for up to three years. These questionnaires take about 10 to 15 minutes to complete and help assess patients' experiences living with MGUS or SMM. Throughout the study, patients provide information via these questionnaires at baseline and scheduled intervals. Researchers use this data to monitor quality of life and anxiety related to their condition. The primary outcome is the results from these questionnaires collected over up to three years, helping to better understand patient needs and concerns.
CONDITIONS
Brief Title
Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older with monoclonal gammopathy of unknown significance (MGUS).
- MGUS patients must have serum monoclonal protein less than 3 g/dL or urinary monoclonal protein less than 500 mg per 24 hours and less than 10% clonal bone marrow plasma cells.
- MGUS patients must have no myeloma defining events or amyloidosis.
- Patients aged 18 years or older with smoldering multiple myeloma (SMM).
- SMM patients must have serum monoclonal protein 3 g/dL or higher or urinary monoclonal protein 500 mg or higher per 24 hours and/or 10-60% clonal bone marrow plasma cells.
- SMM patients must have no myeloma defining events or amyloidosis.
- Patients must be enrolled in clinical trials for SMM or MGUS at MD Anderson Cancer Center.
- Participants must speak English or Spanish.
You will not qualify if you...
- Evidence of myeloma defining events or biomarkers of malignancy including hypercalcemia, renal insufficiency, anemia, bone lesions, clonal bone marrow plasma cells 60% or higher, involved:uninvolved serum free light chain ratio 100 or higher, or more than 1 focal lesion on MRI.
- Plasma cell leukemia.
- Presence of cognitive impairment or delirium as determined by the primary clinician.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 years
Participants complete quality of life questionnaires to assess their health and anxiety related to monoclonal gammopathy of unknown significance or smoldering multiple myeloma.
Questionnaires completed at baseline and every 6 months for observational study participants
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Melody Becnel, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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