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Predicting Progression of Developing Myeloma in a High-Risk Screened Population, PROMISE Study
Trial Status: active
This study collects blood samples to analyze for precursor conditions to multiple myeloma such as monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). Information gained from this study may help to identify risk factors for progression from MGUS or SMM to symptomatic multiple myeloma.
Inclusion Criteria
Must meet criteria of the high-risk population as described with one of the below criteria:
* Age ≥ 30 years AND:
** AA race (self identified); and/or
** First-degree relative of a patient with a plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenström’s Macroglobulinemia, or another blood cancer
OR
* Age ≥ 18 years with 2 or more first- or second-degree relatives with a plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenström’s Macroglobulinemia, or another blood cancer
Exclusion Criteria
* Persons diagnosed with cancer at any site (including hematologic cancers) with symptomatic disease requiring active therapy
* Persons with an already diagnosed plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenström’s Macroglobulinemia
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03689595.
I. To determine clinical/genomic alterations present in individuals with monoclonal gammopathies who are diagnosed through screening of a high-risk population.
II. To determine clinical/genomic/epigenetic and immune environmental predictors of progression to myeloma in patients with monoclonal gammopathies.
SECONDARY OBJECTIVES:
I. Define the prevalence and incidence of MGUS/SMM in a high-risk population of African Americans (AAs) and family history positive individuals.
II. Define germline characteristics of MGUS/SMM in AAs and family history positive cases.
III. Determine the natural history of screen-detected versus (vs.) incidentally detected MGUS/SMM.
IV. Determine the clinical and epidemiological risk factors for progression of MGUS/SMM to multiple myeloma (MM) in a high-risk population of AA and family positive cases.
OUTLINE: This is an observational study.
Participants undergo collection of blood samples and have their medical records reviewed on study. Participants who test positive for a precursor condition may be followed up every 3-6 months. Participants who test negative are followed up every 3 years.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationDana-Farber Harvard Cancer Center
