NCT03689595

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
89mo left

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Oct 2018Oct 2033

First Submitted

Initial submission to the registry

September 20, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 31, 2018

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2033

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

15 years

First QC Date

September 20, 2018

Last Update Submit

July 30, 2026

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

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

    Progression to symptomatic multiple myeloma

    15 years

Study Arms (2)

Cohort 1

Healthy individuals who meet this protocols high-risk criteria for developing MM in their lifetime. * 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.

Other: 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.

Cohort 2

People who have screened positive by mass spectrometry in the Ghobrial Lab for SMM or MGUS as part of the Mass General Brigham Biobank. * 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.

Other: 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.

Interventions

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.OTHER

Collection of blood sample from participants

Cohort 1Cohort 2

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All special populations who fall within the eligible high-risk age range, ≥ 30 years of age are included.

You may qualify if:

  • 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
  • Screened positive by mass spectrometry in the Ghobrial Lab for SMM or MGUS as part of the Mass General Brigham Biobank arm AND fits one of the following two groups of 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.
  • OR • Those over 18 are also eligible if they have 2 or more family members with a blood cancer
  • Screened positive by mass spectrometry in the Ghobrial Lab for SMM or MGUS as part of the Mass General Brigham Biobank arm AND fits the criteria listed below:
  • Age ≥ 18 years

You may not qualify if:

  • 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
  • Persons under the age of 18 years old
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (3)

  • Bertamini L, Alberge JB, Lee DJ, El-Khoury H, Kim S, Fleming G, Murphy C, Colchie J, Davis MI, Perry J, Lightbody ED, Allam S, Goqwana LN, Philip V, Smyth N, Sakrikar D, Perkins M, Harding S, Troske D, Getz G, Karlson EW, Munshi N, Anderson KC, Trippa L, Marinac CR, Chen WC, Joffe M, Ghobrial IM. Serum free light chains in a racially diverse population including African Americans and populations from South Africa. Blood. 2025 Feb 20;145(8):840-849. doi: 10.1182/blood.2024026078.

    PMID: 39571144DERIVED

  • Lee DJ, El-Khoury H, Tramontano AC, Alberge JB, Perry J, Davis MI, Horowitz E, Redd R, Sakrikar D, Barnidge D, Perkins MC, Harding S, Mucci L, Rebbeck TR, Ghobrial IM, Marinac CR. Mass spectrometry-detected MGUS is associated with obesity and other novel modifiable risk factors in a high-risk population. Blood Adv. 2024 Apr 9;8(7):1737-1746. doi: 10.1182/bloodadvances.2023010843.

    PMID: 38212245DERIVED

  • 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.

    PMID: 35344689DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

We collect blood samples from participants to test for precursor conditions to multiple myeloma.

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Irene Ghobrial, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 20, 2018

First Posted

September 28, 2018

Study Start

October 31, 2018

Primary Completion (Estimated)

October 31, 2033

Study Completion (Estimated)

October 31, 2033

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)