Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma ORIGIN STUDY

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Additional Trial Information

Observational Trial

Enrollment: 200 patients (estimated)

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Trial Locations

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Texas

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting
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