Multiple Myeloma
Conditions
Keywords
Multiple Myeloma
Brief summary
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.
Detailed description
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.
Interventions
OTHERSamples 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.
Collection of blood sample from participants
Sponsors
Dana-Farber Cancer Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for Cohort 1: * 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. OR • Those over 18 are also eligible if they have 2 or more family members with a blood cancer Inclusion Criteria for Cohort 2A: Screened positive by mass spectrometry in the Ghobrial Lab for SMM or MGUS as part of the Mass General Brigham Biobank arm AND fits one of the following two groups of 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. OR • Those over 18 are also eligible if they have 2 or more family members with a blood cancer Inclusion Criteria for Cohort 2B: Screened positive by mass spectrometry in the Ghobrial Lab for SMM or MGUS as part of the Mass General Brigham Biobank arm AND fits the criteria listed below: • Age ≥ 18 years
Exclusion criteria
for Cohort 1: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression (TTP) from MGUS/SMM to overt multiple myeloma. | 15 years | Progression to symptomatic multiple myeloma |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORIrene Ghobrial, MD
Dana-Farber Cancer Institute
Outcome results
None listed