Screening for AL Amyloidosis in Smoldering Multiple Myeloma
This study is looking for 400 patients, aged 40 or older, who have been diagnosed with Smoldering Multiple Myeloma (SMM) or Monoclonal Gammopathy. SMM is a condition where abnormal plasma cells are found in the bone marrow, but it doesn't cause symptoms and usually doesn't require immediate treatment. The main goal of this study is to find out if patients with SMM also have light-chain amyloidosis (AL), a serious condition, before they start showing symptoms. Researchers will collect blood and bone marrow samples to look for specific genetic markers (IGLV genes) and other factors that might indicate a higher risk of AL. The study aims to develop a way to predict who might have or develop AL, so it can be diagnosed earlier.
- Study design
- This is an observational study involving 400 participants. It is not testing a specific treatment, but rather observing and collecting data.
- What's involved
- You would be asked to provide bone marrow and blood specimens. The study aims to collect data over a period of 5 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study plans to collect data and validate an assay over a period of 5 years.
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Screening for AL Amyloidosis in Smoldering Multiple Myeloma
At a glance
Conditions
Where it's being run
13 sites across 10 statesWho to contact
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What this trial measures
- Creating a network to enroll patients on a collaborative study requiring marrow and blood specimens, to collect data for a training set of likelihood statistics and to plan a future validation study.5 years
With a 15-center network covering 12 states and almost 45% of the US population, we will evaluate 400 SMM patients \> 40 years old who pass FLC criteria using standard of care tests including NT-proBNP and clinical marrow specimens evaluated for the presence of t(11;14) and gain1q. Marrow cells will be processed by NGS for clonal IGLV gene identification. With the training data obtained, we will use existing statistical modeling techniques to generate a statistical algorithm for identifying undiagnosed cases of AL and assessment of risk of AL, and to plan a validation study testing the training model. We will also investigate a role for the novel biomarker clusterin (Clu) as an indicator of risk of AL in SMM patients; preliminary work indicates that Clu is significantly lower in AL than in SMM patients.
- Validating an NGS assay that identifies IGLV genes in clonal plasma cells5 years
All subjects will have their clonal IGLV genes identified by NGS enabling the creation and validation of a laboratory developed test in a precision medicine laboratory that is certified under regulations of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Approval for this laboratory developed test for both κ and λ IGVL genes will permit providers, patients and researchers to use the test in decision-making to care for monoclonal gammopathy patients. We will also investigate the exploratory objective of defining the alterations in sequence in AL and non-AL FLC derived from the same IGLV germline gene.