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Studies blood samples to predict multiple myeloma in high-risk people

Collects blood samples from people with early myeloma precursor conditions to study risk factors.

Key facts

Who runs it
Dana-Farber Cancer Institute
Where
Boston, United StatesSee the site
Trial code
Registry title
Predicting Progression of Developing Myeloma in a High-Risk Screened Population (PROMISE)
Status
Enrolling by invitation
People taking part
30,000 people, planned
Started
31 Oct 2018
Expected to end
31 Oct 2033
Type of study
Observational, 2 groups
Treatments tested
  • 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.
Record updated
31 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people at higher risk of multiple myeloma, such as African American people or those with a close relative with a blood cancer. It also includes people who screened positive for MGUS or smoldering myeloma.

Age
30 years or older. People 18 or older can join if they have 2 or more family members with a blood cancer, or in cohort 2B (screened positive).
Sex
All sexes can join.
Disease stage
Cohort 1: no diagnosed plasma cell disorder (MGUS, SMM, MM, Waldenström's). Cohorts 2A and 2B: screened positive by mass spectrometry for SMM or MGUS.
Biomarker or test result
Cohorts 2A and 2B: positive screening by mass spectrometry in the Ghobrial Lab for SMM or MGUS.

Main reasons for not taking part

  • Cohort 1: cancer with symptoms that needs active treatment
  • Cohort 1: already diagnosed with MGUS, SMM, MM or Waldenström's Macroglobulinemia
  • Cohorts 2A and 2B: under 18 years old

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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
  • 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
  • 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

Who cannot take part

  • Persons diagnosed with cancer at any site (including hematologic cancers) with symptomatic disease requiring active therapy
  • 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
  • Persons with an already diagnosed plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenström's Macroglobulinemia

Where in United States

  • Dana-Farber Cancer InstituteBoston, United StatesEnrolling by invitation

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Cohort 1

    Healthy individuals who meet this protocols high-risk criteria for developing MM in their lifetime. * 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.

    Treatment: 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.

  • Cohort 2

    People who have screened positive by mass spectrometry in the Ghobrial Lab for SMM or MGUS as part of the Mass General Brigham Biobank. * 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.

    Treatment: 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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Predicting Progression of Developing Myeloma in a High-Risk Screened Population (PROMISE)
Plain-language title
Studies blood samples to predict multiple myeloma in high-risk peopleGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
31 July 2026