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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03689595
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : June 23, 2021
Stand Up To Cancer
Information provided by (Responsible Party):
Irene Ghobrial, MD, 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.

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated Enrollment : 50000 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 : October 31, 2018
Estimated Primary Completion Date : October 31, 2033
Estimated Study Completion Date : October 31, 2033

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort 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

Primary Outcome Measures :
  1. Time to progression (TTP) from MGUS/SMM to overt multiple myeloma. [ Time Frame: 15 years ]
    Progression to symptomatic multiple myeloma

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All special populations who fall within the eligible high-risk age range, ≥ 45 and ≤75

Inclusion Criteria:

  • Age ≥ 45 and ≤75
  • AA race (self-identified) and/or first-degree relative of a patient with a blood cancer such as leukemia, lymphoma, MGUS, SMM, multiple myeloma, and Waldenström Macroglobulinemia
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03689595

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Contact: Irene Ghobrial, MD 617-632-4198

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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Irene Ghobrial, MD    617-632-4198   
Principal Investigator: Irene Ghobrial, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Stand Up To Cancer
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Principal Investigator: Irene Ghobrial, MD Dana-Farber Cancer Institute
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Responsible Party: Irene Ghobrial, MD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT03689595    
Other Study ID Numbers: 18-370
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: June 23, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Irene Ghobrial, MD, Dana-Farber Cancer Institute:
Multiple Myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases