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

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Other: Sample of Blood

• Registration Number: NCT03689595
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Study Timeline

• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-09-28
• Study Start: 2018-10-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-24
• Primary Completion: 2033-10-31
• Study Completion: 2033-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Specimen Collection	Sample of Blood	* 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.

Primary Outcome Measures

Name	Time	Method
Time to progression (TTP) from MGUS/SMM to overt multiple myeloma.	15 years	Progression to symptomatic multiple myeloma

Trial Locations

Locations (1)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States