Clinical Trial 21219

• Overview

  Study Title:

  Predicting Progression of Developing Myeloma in a High-Risk Screened Population

  Summary:

  The purpose of the PROMISE research study is to analyze blood for precursor conditions to multiple myeloma such as monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM).

  Objective:

  Primary Objectives To determine clinical/genomic alterations present in individuals with monoclonal gammopathies who are diagnosed though screening of a high-risk population. To determine clinical/genomic/epigenetic and immune environmental predictors of progression to myeloma in patients with monoclonal gammopathies. Secondary Objectives Define the prevalence and incidence of MGUS/SMM in a high-risk population of AAs and family history positive individuals. Define germline characteristics of MGUS/SMM in AAs and family history positive cases. Determine the natural history of screen-detected vs. incidentally detected MGUS/SMM. The present study of screened-detected MGUS/SMM can be compared to our PCROWD cohort of MGUS/SMM individuals incidentally diagnosed and longitudinally followed. Determine the clinical and epidemiological risk factors for progression of MGUS/SMM to MM in a high-risk population of AA and family positive cases.

• Inclusion Criteria

  Inclusion Criteria:
  • Between 40 and 75 years of age
  • Self identifies as African American and/or first degree relative of a patient with a plasma cell dyscrasia such as MGUS, SMM, MM and Waldenstrom's Macroglobulinemia, or another blood cancer
  • For participants with a strong family history (2 relatives with blood cancers) their first and second degree relatives will be allowed to participate if 18 years or older.

• Exclusion Criteria

  Exclusion Criteria:
  • Persons diagnosed with cancer at any site (including hematologic cancers) with symptomatic disease requiring active therapy.
  • Persons diagnosed with plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenstrom's Macroglobulinemia.

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.