Predicting Progression of Developing Myeloma in a High-Risk Screened Population (PROMISE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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..
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other 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.
Collection of blood sample from participants
Primary outcome measures
- Time to progression (TTP) from MGUS/SMM to overt multiple myeloma. [Time frame: 15 years]
Eligibility criteria
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
Exclusion Criteria for Cohort 2A and 2B:
- Persons under the age of 18 years old
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Dana Farber Cancer Institute — Boston
Publications
- Bertamini L, Alberge JB, Lee DJ, El-Khoury H, Kim S, Fleming G, Murphy C, Colchie J, Davis MI, Perry J, Lightbody ED, Allam S, Goqwana LN, Philip V, Smyth N, Sakrikar D, Perkins M, Harding S, Troske D, Getz G, Karlson EW, Munshi N, Anderson KC, Trippa L, Marinac CR, Chen WC, Joffe M, Ghobrial IM. Serum free light chains in a racially diverse population including African Americans and populations f PMID 39571144
- Lee DJ, El-Khoury H, Tramontano AC, Alberge JB, Perry J, Davis MI, Horowitz E, Redd R, Sakrikar D, Barnidge D, Perkins MC, Harding S, Mucci L, Rebbeck TR, Ghobrial IM, Marinac CR. Mass spectrometry-detected MGUS is associated with obesity and other novel modifiable risk factors in a high-risk population. Blood Adv. 2024 Apr 9;8(7):1737-1746. doi: 10.1182/bloodadvances.2023010843. PMID 38212245
- El-Khoury H, Lee DJ, Alberge JB, Redd R, Cea-Curry CJ, Perry J, Barr H, Murphy C, Sakrikar D, Barnidge D, Bustoros M, Leblebjian H, Cowan A, Davis MI, Amstutz J, Boehner CJ, Lightbody ED, Sklavenitis-Pistofidis R, Perkins MC, Harding S, Mo CC, Kapoor P, Mikhael J, Borrello IM, Fonseca R, Weiss ST, Karlson E, Trippa L, Rebbeck TR, Getz G, Marinac CR, Ghobrial IM. Prevalence of monoclonal gammopathi PMID 35344689
Identifiers
NCT: NCT03689595 · 18-370