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

• ClinicalTrials.gov Identifier: NCT03689595
• Recruitment Status: Recruiting
• First Posted: September 28, 2018
• Last Update Posted: March 24, 2022
• Sponsor: Dana-Farber Cancer Institute
• Collaborator: Stand Up To Cancer
• Information provided by (Responsible Party): Irene Ghobrial, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: September 20, 2018
• First Posted Date: September 28, 2018
• Last Update Posted Date: March 24, 2022
• Actual Study Start Date: October 31, 2018
• Estimated Primary Completion Date: October 31, 2033 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 26, 2018)

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

Progression to symptomatic multiple myeloma

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Predicting Progression of Developing Myeloma in a High-Risk Screened Population (PROMISE)
• Official Title: Predicting Progression of Developing Myeloma in a High-Risk Screened Population (PROMISE)
• 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 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: All special populations who fall within the eligible high-risk age range, ≥ 30 years of age
• Condition: Multiple Myeloma

Intervention

Other: Sample of Blood

Collection of blood sample from participants

Study Groups/Cohorts

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

Intervention: Other: Sample of Blood

• Publications *: El-Khoury H, Lee DJ, Alberge JB, Redd R, Cea-Curry CJ, Perry J, Barr H, Murphy C, Sakrikar D, Barnidge D, Bustoros M, Leblebjian H, Cowan A, Davis MI, Amstutz J, Boehner CJ, Lightbody ED, Sklavenitis-Pistofidis R, Perkins MC, Harding S, Mo CC, Kapoor P, Mikhael J, Borrello IM, Fonseca R, Weiss ST, Karlson E, Trippa L, Rebbeck TR, Getz G, Marinac CR, Ghobrial IM. Prevalence of monoclonal gammopathies and clinical outcomes in a high-risk US population screened by mass spectrometry: a multicentre cohort study. Lancet Haematol. 2022 May;9(5):e340-e349. doi: 10.1016/S2352-3026(22)00069-2. Epub 2022 Mar 25.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 22, 2022): 30000
• Original Estimated Enrollment (submitted: September 26, 2018): 50000
• Estimated Study Completion Date: October 31, 2033
• Estimated Primary Completion Date: October 31, 2033 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Irene Ghobrial, MD; 617-632-4198; Irene_Ghobrial@dfci.harvard.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03689595
• Other Study ID Numbers: 18-370
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Irene Ghobrial, MD, Dana-Farber Cancer Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: Stand Up To Cancer

Investigators

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

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: March 2022