Predicting Progression of Developing Myeloma in a High-Risk Screened Population and General Population

NCT05837884 | Recruiting

• 1 other identifier: PROMISE-ISRAEL
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 3

Brief Summary

We will seek consent from participants to use the data and biospecimens collected according study protocol to address additional research questions for MGUS, SMM, MM, and other conditions. Our overarching hypothesis is that early detection of MGUS/SMM in a high- risk population, along with the comprehensive characterization of genomic/epigenomic and microenvironmental/immune regulators of disease progression will lead to strategies that intercept disease progression and improve survival.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Prevalence and Incidence

  Prevalence and Incidence of Monoclonal gammopathy of undetermined signiificance (MGUS)/smoldering multiple myeloma (SMM) in a high-risk population of family history positive individuals

  Every individual will have a different duration throughout the study depending on their diagnosis.

Secondary Outcomes (3)

• Presence of clinical alterations

  Every individual will have a different duration throughout the study depending on their diagnosis.

• Determination of natural history of screen-detected vs. incidentally detected MGUS/SMM

  Every individual will have a different duration throughout the study depending on their diagnosis.

• Determination clinical and epidemiological risk factors

  Every individual will have a different duration throughout the study depending on their diagnosis.

Study Arms (2)

First-degree relative of a patient with a plasma cell dyscrasia or another blood cancer.

Individuals will ensure they are eligible by filling out an eligibility questionnaire confirming they meet all eligibility criteria. Individuals will provide informed consent to complete the baseline questionnaire and provide a blood sample that will be used to determine whether they have a monoclonal protein

Diagnostic Test: blood sampling

Control group

The individuals without a relative of a patient with a plasma cell dyscrasia or another blood cancer. This group will undergo the same procedures as the first-degree participants and these data will be used for comparison between the populations.

Diagnostic Test: blood sampling

Interventions

blood sampling DIAGNOSTIC_TEST

Participants will provide a blood sample that will be used to determine whether they have a monoclonal protein

Control group; First-degree relative of a patient with a plasma cell dyscrasia or another blood cancer.

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy individuals who are first-degree relatives of hematological patients and A control group of healthy individuals who are not related to hematological patients

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: collaborator
• Tel-Aviv Sourasky Medical Center: lead

Study Sites (3)

Soroka

Beersheba, Israel

RECRUITING

Rabin medical center

Petah Tikva, Israel

RECRUITING

TASMC

Tel Aviv, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Irit Avivi, Prof

CONTACT

-97236973782; iritavi@tlvmc.gov.il

Ella Krayzler

CONTACT

-97236947231; ellakr@tlvmc.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 1, 2023
• Study Start: September 5, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 4, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3)