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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03689595
• Other study ID #: 18-370
• Status: Recruiting
• Start date: October 31, 2018
• Est. completion date: October 31, 2033

Study information

• Verified date: July 2023
• Source: Dana-Farber Cancer Institute
• Contact: Irene Ghobrial, MD
• Phone: 617-632-4198
• Email: Irene_Ghobrial[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The goal of the PROMISE research study is to determine clinical/genomic alterations present in individuals with MGUS and SMM, who are diagnosed though 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: October 31, 2033
• Est. primary completion date: October 31, 2033
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

We will include 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• Sample of Blood
Collection of blood sample from participants

Locations

Country	Name	City	State
United States	The Johns Hopkins Hospital	Baltimore	Maryland
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Stand Up To Cancer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression (TTP) from MGUS/SMM to overt multiple myeloma.	Progression to symptomatic multiple myeloma	15 years