Prospective Observational Study of Clinical and Genomic Predictors of Progression to Myeloma in Asymptomatic Monoclonal Gammopathies

Overview

The goal of this clinical research study is to find markers that might help predict why some patients with monoclonal gammopathy of unknown significance (MGUS) and smoldering multiple myeloma (SMM) develop multiple myeloma, while others do not. Markers that will be studied may include participant's age, level of proteins in blood and urine, percent of abnormal blood cells in the bone marrow, genes in the abnormal blood cells, and bone abnormalities.

SparkCures ID 877
Trial Phase Observational Trial
Enrollment 200 Patients
Trial Sponsors
  • MD Anderson Cancer Center
NCT Identifier

NCT02726750

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  1. Patients with monoclonal gammopathy of unknown significance age ≥ 18 years old.
    1. Both criteria must be met:
      1. Serum monoclonal protein < 3 g/dL or urinary monoclonal protein < 500 mg per 24 hours and clonal bone marrow plasma cells <10%
      2. Absence of myeloma defining events or amyloidosis
  2. Patients with smoldering multiple myeloma age ≥ 18 years old.
    1. Both criteria must be met:
      1. Serum monoclonal protein ≥ 3 g/dL or urinary monoclonal protein ≥ 500 mg per 24 hours and/or clonal bone marrow plasma cells 10-60%
      2. Absence of myeloma defining events or amyloidosis

Exclusion Criteria:

  1. 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, UK)
    • >1 focal lesions on MRI studies (each focal lesion must be 5 mm or more in size)
  2. 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
  3. Plasma cell leukemia
  4. Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness/social situations that would compromise compliance with study requirements

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Texas

Resources

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