Predicting progression of myeloma in high-risk individuals
Predicting Progression of Developing Myeloma in a High-Risk Screened Population and General Population
This study is testing ways to spot early signs of myeloma in people at high risk, like those with a family history, to see if starting treatment sooner can help them live longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Tel-Aviv Sourasky Medical Center Government |
| Locations | 3 sites (Beersheba and 2 other locations) |
| Trial ID | NCT05837884 on ClinicalTrials.gov |
What this trial studies
This study aims to collect data and biospecimens from participants to investigate the early detection of monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM) in a high-risk population. By characterizing genomic, epigenomic, and immune factors associated with disease progression, the research seeks to develop strategies that can intercept the progression of these conditions. The study will involve blood sampling and will focus on individuals with a family history of plasma cell dyscrasias. The overarching goal is to improve survival rates by initiating treatment before the onset of symptomatic disease.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 30 and older with a family history of plasma cell dyscrasias or those aged 18 and older with multiple relatives affected by these conditions.
Not a fit: Patients who have already been diagnosed with any form of cancer or plasma cell dyscrasia will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier interventions that significantly improve survival rates for individuals at high risk of developing multiple myeloma.
How similar studies have performed: While the approach of early detection and intervention in high-risk populations is gaining traction, this specific study's methodology is novel and has not been extensively tested in prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must meet criteria of the high-risk population as described with one of the below criteria * ≥ 30 years AND * first-degree relative of a patient with a plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenström's Macroglobulinemia, or another blood cancer. OR * Age ≥ 18 years with 2 or more first- or second-degree relatives with a plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenström's Macroglobulinemia, or another blood cancer ' * Voluntary written informed consent must be given with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care 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 * Female patient who have a positive serum pregnancy test during the screening period or a positive pregnancy test.
Where this trial is running
Beersheba and 2 other locations
- Soroka — Beersheba, Israel (Recruiting)
- Rabin medical center — Petah Tikva, Israel (Recruiting)
- Tasmc — Tel Aviv, Israel (Recruiting)
Study contacts
- Study coordinator: Irit Avivi, Prof
- Email: iritavi@tlvmc.gov.il
- Phone: -97236973782
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.