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

ConditionHealthy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30+
SponsorTel-Aviv Sourasky Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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 '

Disqualifiers

• 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.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • blood sampling

    Diagnostic test

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

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: First-degree relative of a patient with a plasma cell dyscrasia or another blood cancer.1 intervention
Group B: Control group1 intervention

Trial outcomes

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

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

Secondary outcomes

1

Presence of clinical alterations

one of the objectives of the trial is to determine clinical alterations present in individuals with monoclonal gammopathies who are diagnosed through screening of a high- risk population.

Time frame
Every individual will have a different duration throughout the study depending on their diagnosis.
2

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

One of the objectives of the trial to determine the natural history of screen-detected vs. incidentally detected MGUS/SMM. The present study of screened-detected MGUS/SMM can be compared to Dana-Farber Cancer Institute, Department of Hematologic Malignancies cohort of MGUS/SMM individuals incidentally diagnosed and longitudinally followed.

Time frame
Every individual will have a different duration throughout the study depending on their diagnosis.
3

Determination clinical and epidemiological risk factors

One of the objectives of the trial to determine the clinical and epidemiological risk factors for progression of MGUS/SMM to MM in a high-risk population of family positive cases.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tel-Aviv Sourasky Medical Center

Lead sponsor

Dana-Farber Cancer Institute

Collaborator

Source ClinicalTrials.gov
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