Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma

Recruiting now

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

In brief

The goal of this study is to find markers that may help to predict why some patients who have monoclonal gammopathy of unknown significance (MGUS) or smoldering multiple myeloma (SMM) that have no signs or symptoms of disease (asymptomatic) develop multiple myeloma, while others do not. Studying markers such as age, level of proteins in blood, percent of abnormal blood cells in the bone marrow, genes in the abnormal blood cells, and bone abnormalities may help researchers to validate clinical and genomic predictors for future use in clinical practice.

Key facts

Study ID

NCT02726750

Run by

M.D. Anderson Cancer Center

People needed

200

Starts

2015-12-14

Expected to finish

2028-04-30

Last updated by the study team

2026-04-21

Who can join

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

You may qualify if…

• Patients with monoclonal gammopathy of unknown significance. 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
• Patients with smoldering multiple myeloma. 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

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 (each focal lesion must be 5 mm or more in size)
• Prior or concurrent systemic treatment for asymptomatic monoclonal gammopathies
• Bisphosphonates are permitted
• Radiotherapy is not permitted
• Prior treatment with chemotherapy or investigational agents for asymptomatic gammopathies is not permitted
• Plasma cell leukemia
• Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness/social situations that would compromise compliance with study requirements

Where it is running

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

Full record on ClinicalTrials.gov

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