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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-31

Study Completion Date

2033-10-31

Brief Summary

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The PROMISE Study aims to establish a prospective cohort of individuals with precursor conditions to multiple myeloma, such as monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). We will study these patients as a means to identify risk factors for progression to symptomatic multiple myeloma.

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Detailed Description

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The goal of the PROMISE research study is to determine clinical/genomic alterations present in individuals with MGUS and SMM, who are diagnosed through screening of a high-risk population. We also seek to determine clinical/genomic/epigenetic and immune environmental predictors of progression to multiple myeloma in patients with MGUS and SMM.

Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Specimen Collection

* Samples of blood (2-4 tablespoons) from 4 tubes will be collected
* Analysis will be performed on the blood to test for multiple myeloma precursor conditions.

Sample of Blood

Intervention Type OTHER

Collection of blood sample from participants

Interventions

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Sample of Blood

Collection of blood sample from participants

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 30 years
* 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.
* Those over 18 are also eligible if they have 2 or more family members with a 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

First-degree relatives would not need to be identified by the participant.

This study includes all special populations who fall within the eligible high-risk age range, ≥ 30 years of age, including adults unable to consent, pregnant women, and prisoners. These populations will not be excluded as this is a non-therapeutic study.

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes