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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT03689595

Collaborator

Stand Up To Cancer (Other)

30,000

Enrollment

Locations

180

Anticipated Duration (Months)

10000

Patients Per Site

55.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Other: Sample of Blood

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 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

30000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 31, 2018

Anticipated Primary Completion Date :

Oct 31, 2033

Anticipated Study Completion Date :

Oct 31, 2033

Arms and Interventions

Arm	Intervention/Treatment
Specimen Collection Samples of blood (2-4 tablespoons) from 3 tubes will be collected Analysis will be performed on the blood to test for multiple myeloma precursor conditions once sent to outside labs at Mayo Clinic and the Broad Institute	Other: Sample of Blood Collection of blood sample from participants

Arm

Intervention/Treatment

Specimen Collection

Samples of blood (2-4 tablespoons) from 3 tubes will be collected Analysis will be performed on the blood to test for multiple myeloma precursor conditions once sent to outside labs at Mayo Clinic and the Broad Institute

Other: Sample of Blood

Collection of blood sample from participants

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
2	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
3	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Dana-Farber Cancer Institute
Stand Up To Cancer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT03689595

Other Study ID Numbers:

18-370

First Posted:

Sep 28, 2018

Last Update Posted:

Mar 24, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Irene Ghobrial, MD, Principal Investigator, Dana-Farber Cancer Institute

Multiple Myeloma

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Study Results

No Results Posted as of Mar 24, 2022