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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03689595
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Accepted

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

Study Details

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.

Key Dates

First listed
Sep 28, 2018
Start date
Oct 31, 2018
Status verified
Jul 2026
Primary completion
Oct 31, 2033
Completion
Oct 31, 2033

Study Design

Enrollment
30,000 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-

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