Identifying risk factors for progression of multiple myeloma in high-risk individuals
Predicting Progression of Developing Myeloma in a High-Risk Screened Population (PROMISE)
Dana-Farber Cancer Institute · NCT03689595
This study is trying to find out what factors might lead to the progression of multiple myeloma in people who are already at high risk for the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30000 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03689595 on ClinicalTrials.gov |
What this trial studies
The PROMISE study establishes a prospective cohort of individuals with precursor conditions to multiple myeloma, such as monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). It aims to identify clinical, genomic, and epigenetic alterations that may predict progression to symptomatic multiple myeloma. Participants are screened from a high-risk population, and blood samples are collected for analysis. This observational study focuses on understanding the immune environment and other risk factors associated with disease progression.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 30 and older who are African American or have a family history of blood cancers.
Not a fit: Patients already diagnosed with symptomatic cancer or those with an existing plasma cell dyscrasia will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and early intervention strategies for individuals at high risk of developing multiple myeloma.
How similar studies have performed: Other studies have shown promise in identifying risk factors for multiple myeloma progression, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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. 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.
Where this trial is running
Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Irene Ghobrial, MD — Dana-Farber Cancer Institute
- Study coordinator: Irene Ghobrial, MD
- Email: promisestudy@partners.org
- Phone: 617-632-4198
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Myeloma