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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief Summary:

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.


Detailed Summary:

Study Visits:

If participant is found to be eligible to take part in this study, every 6 months for 3 years:

  • Participant will have a physical exam.
  • Blood (about 1-2 tablespoons) will be collected for biomarker and routine tests and to check the status of the disease.
  • A 24 hour urine sample will be collected for routine tests.
  • If the doctor thinks it is needed, participant will have a bone marrow biopsy and aspiration, PET/CT scan, and/or MRI. This may be done, for example, if participant is not feeling well or if there is a concern that the disease might be developing into multiple myeloma.

One (1) time a year for 3 years, participant will have x-rays to check the status of the disease if the doctor thinks it is needed.

Length of Study:

Participant will be taken off study if they decide to receive chemotherapy or other treatments for the disease during the first 3 years or if they are unable to follow directions. Participant will enter the follow-up period early if the disease gets worse.

End-of-Study Visit:

After 3 years on study, the following tests and procedures will be performed:

  • Blood (about 1-2 tablespoons) will be collected for routine tests, biomarker tests, and to check the status of the disease.
  • A 24 hour urine sample will be collected for routine tests.
  • Participant will have
    Sponsor: M.D. Anderson Cancer Center

    Current Primary Outcome: Rate of Progression to Multiple Myeloma [ Time Frame: 3 years ]

    Kaplan-Meier method used to estimate the time-to-event endpoints.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: M.D. Anderson Cancer Center

    Dates:
    Date Received: March 30, 2016
    Date Started: December 2015
    Date Completion:
    Last Updated: October 3, 2016
    Last Verified: October 2016