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NCT Number: NCT03689595

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

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.

Recruiting

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Irene Ghobrial, MD

CONTACT

[email protected]

617-632-4198

Irene Ghobrial, MD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sample of Blood

Other

Collection of blood sample from participants

Primary outcomes

  1. Time to progression (TTP) from MGUS/SMM to overt multiple myeloma.

    Time frame: 15 years

    Progression to symptomatic multiple myeloma

Study contacts

Contact information is provided by the study sponsor or research team.

Irene Ghobrial, MD

CONTACT

[email protected]

617-632-4198

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Important dates

Study start
2018
Primary completion
2033
Study completion
2033
First posted
Sep 28, 2018
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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