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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.
 
ClinicalTrials.gov Identifier: NCT03689595
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : March 24, 2022
Sponsor:
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
Change History
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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