Quality of Life in Patients With Asymptomatic Monoclonal Gammopathies

Recruiting now

Conditions studied: Monoclonal Gammopathy of Undetermined Significance, Smoldering Plasma Cell Myeloma

In brief

This study examines the quality of life in patients with monoclonal gammopathy of unknown significance and smoldering multiple myeloma. Collecting quality of life information from patients may help doctors learn more about the most common symptoms and concerns patients with monoclonal gammopathy of unknown significance and smoldering multiple myeloma may have.

Key facts

Study ID

NCT05136807

Run by

M.D. Anderson Cancer Center

People needed

400

Starts

2016-06-07

Expected to finish

2027-02-02

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with either monoclonal gammopathy of unknown significance age >= 18 years old.
• Both criteria must be met:
• Serum monoclonal protein < 3 g/dL or urinary monoclonal protein < 500 mg per 24 hours and clonal bone marrow plasma cells < 10%
• Absence of myeloma defining events or amyloidosis
• OR Patients with smoldering multiple myeloma age >= 18 years old.
• Both criteria must be met:
• Serum monoclonal protein >= 3 g/dL or urinary monoclonal protein >= 500 mg per 24 hours and/or clonal bone marrow plasma cells 10-60%
• Absence of myeloma defining events or amyloidosis
• Patients must be enrolled in clinical trials for SMM or MGUS at MD Anderson Cancer Center, including protocols PA15-0575 (NCT02726750) (Prospective observational study of clinical and genomic predictors of progression to myeloma in asymptomatic monoclonal gammopathies); 2015-0148 (Phase II single arm trial of Isatuximab in patients with intermediate and high risk smoldering multiple myeloma); and 2015-0371 (NCT02603887) (Pilot single arm, single center, open label trial of Pembrolizumab in patients with intermediate and high risk smoldering multiple myeloma) and any future clinical trials for MGUS and/or SMM that open at MD Anderson Cancer Center.
• Only patients who are English or Spanish speaking are eligible.

You may not qualify if…

• Evidence of myeloma defining events or biomarkers of malignancy due to underlying plasma cell proliferative disorder meeting at least one of the following
• Hypercalcemia: serum calcium > 0.25 mmol/L (> 1 mg/dL) higher than the upper limit of normal or > 2.75 mmol/L (> 11 mg/dL)
• Renal Insufficiency: creatinine clearance < 40 ml/min or serum creatinine > 2 mg/dL
• Anemia: hemoglobin value < 10 g/dL or 2 g/dL < normal reference
• Bone lesions: one or more osteolytic lesions on skeletal radiography, computerized tomography (CT) or 2-deoxy-2[F-18] fluoro-D-glucose positron emission tomography CT (PET-CT).
• Clonal bone marrow plasma cell percentage >= 60%
• Involved: uninvolved serum free light chain ratio >= 100 measured by Freelite assay (The Binding Site Group, Birmingham, United Kingdom [UK])
• >1 focal lesions on magnetic resonance imaging (MRI) studies, if the patient has an MRI done per eligibility criteria (each focal lesion must be 5 mm or more in size)
• Plasma cell leukemia.
• Presence of cognitive impairment or delirium as determined by the primary clinician.

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.