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

July 30, 2026 updated by: Irene Ghobrial, MD, Dana-Farber Cancer Institute
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All special populations who fall within the eligible high-risk age range, ≥ 30 years of age are included.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression (TTP) from MGUS/SMM to overt multiple myeloma.
Time Frame: 15 years
Progression to symptomatic multiple myeloma
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Stand Up To Cancer

Investigators

  • Principal Investigator: Irene Ghobrial, MD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2018

Primary Completion (Estimated)

October 31, 2033

Study Completion (Estimated)

October 31, 2033

Study Registration Dates

First Submitted

September 20, 2018

First Submitted That Met QC Criteria

September 26, 2018

First Posted (Actual)

September 28, 2018

Study Record Updates

Last Update Posted (Actual)

July 31, 2026

Last Update Submitted That Met QC Criteria

July 30, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-370

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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