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Trial record 60 of 2532 for:    "Plasma Cell Neoplasm"

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

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ClinicalTrials.gov Identifier: NCT03689595
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
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

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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
Criteria

Inclusion Criteria:

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

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 ClinicalTrials.gov identifier (NCT number): NCT03689595


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

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Irene Ghobrial, MD    617-632-4198    Irene_Ghobrial@dfci.harvard.edu   
Principal Investigator: Irene Ghobrial, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Stand Up To Cancer
Investigators
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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
ClinicalTrials.gov Identifier: NCT03689595     History of Changes
Other Study ID Numbers: 18-370
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
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
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases