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Clinical Trial


Clinical and Genomic Predictors of Progression to Myeloma in Patients With Asymptomatic Monoclonal Gammopathies

          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.

Est. Enrollment: 200 participants

The number of participants in a clinical study. The "estimated" enrollment is the target number of participants the researchers need for the study.

Study Start Date: Dec 14, 2015

These are the dates the researchers think the study will start and end.

Study Completion Date: Dec 15, 2022

The "estimated" study completion date is the date the researchers think the last participant in a clinical study was examined or received an intervention/treatment. This is also the expected date that the study will be completed

Age: 18+ years

Gender: All

Who can join expand_less
  • 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
Who cannot join expand_less
  • 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
Study Description expand_more
Study Details expand_more

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