ClinicalTrials.gov record NCT06365060

Screening for AL Amyloidosis in Smoldering Multiple Myeloma

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Screening for AL Amyloidosis in Smoldering Multiple Myeloma

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age40 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational study screens people with smoldering multiple myeloma for undiagnosed light-chain (AL) amyloidosis. It collects standard-of-care blood and bone marrow tests and genetic data to build a training set for a likelihood algorithm.

What it is studying. The study tests whether a combination of factors — a prior diagnosis of smoldering multiple myeloma, free light chain (FLC) abnormalities, use of IGLV genes linked to AL, cytogenetic abnormalities t(11;14) or gain 1q, and NT-proBNP > 332 pg/mL — can identify undiagnosed AL or predict risk of progression. It also aims to validate a next-generation sequencing (NGS) assay to identify clonal IGLV genes and to investigate clusterin (Clu) as a potential biomarker.

What the researchers hope to learn. Create a multicenter training data set to build a statistical algorithm for identifying undiagnosed AL and assessing AL risk in SMM patients; validate an NGS test for clonal IGLV gene identification; investigate clusterin as a biomarker distinguishing AL from SMM.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

In this multicenter study, we will recruit 400 patients 40 years of age or older at 15 centers with a diagnosis of smoldering multiple myeloma (SMM), a group of patients for whom standard of care is observation not treatment. The main goal of this study is to screen for the diagnosis of light-chain amyloidosis (AL) before the onset of symptomatic disease and to develop a training set for a likelihood algorithm.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Patients 40 years of age and older
  • diagnosed with either Smoldering Multiple Myeloma or a Monoclonal Gammopathy
  • dFLC greater than 23 mg/L
  • abnormal FLC ratio
  • If the patient has an eGFR less than 50 mL/min/1.73m2, the FLC ratio is inconsequential. The patient only needs to meet the age and dFLC criterion.

Exclusion criteria

  • Patients younger than 40 years of age are not eligible
  • Patients with a previous finding of amyloid in other biopsies will not be included
  • Adults unable to consent are not eligible, including the cognitively impaired Pregnant women, pregnant minors, minors (i.e., individuals who are not yet adults), wards of the state, non-viable neonates, neonates of uncertain viability, and prisoners are not eligible

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

This study is based on results from two prior studies in which 4 of 36 patients with SMM and none of 14 patients with MGUS were found to have AL. The hypothesis that we test with this protocol is that patients with (1) a pre-existing diagnosis of SMM, (2) free light chain (FLC) abnormalities, (3) IGLV genes associated with AL,(4) t(11;14) or gain 1q, and (5) NT-proBNP > 332pg/mL will have undiagnosed AL or risk of progression to AL. We will study the potential for SMM, the FLC screen, AL-related IGLV gene use, t(11;14) or gain 1q cytogenetic abnormalities, and NT-proBNP > 332pg/mL to be the variables in a likelihood algorithm for AL.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants give blood samples and provide a bone marrow specimen. Standard-of-care blood tests including NT-proBNP and free light-chain measurements will be performed. Bone marrow cells will be analyzed by next-generation sequencing to identify clonal IGLV genes and samples will be used to develop and validate a laboratory test and a statistical likelihood model for AL. Testing and laboratory validation work will be performed on collected clinical specimens; the study does not state additional participant services.

How the study is structured. A prospective observational cohort study. Participants provide blood and clinical bone marrow specimens and undergo standard-of-care tests (including NT-proBNP and cytogenetic evaluation). Marrow cells will be processed by NGS to identify clonal IGLV genes. Data will be used to create a statistical training set; a laboratory-developed NGS test will be validated within the study.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Smoldering Multiple Myeloma. Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on AL amyloidosis

Clinical trials69 trials listed for AL amyloidosisEvery trial the registry lists for AL amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in AL amyloidosis researchLatest monthly update: September 2026. Includes: Daratumumab alone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 1, 2024
Primary completion
Feb 27, 2029 (estimated)
Study completion
Feb 27, 2029 (estimated)
Target enrollment
400 participants (estimated)
Last updated on registry
Aug 6, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Tufts Medical Center
Collaborators
  • National Cancer Institute (NCI)

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (13)

  • University of Alabama HospitalRecruiting

    Birmingham, Alabama, 35233 · United States

  • Cedars-Sinai Medical CenterRecruiting

    Los Angeles, California, 90048 · United States

    • Robert Vescio, MD
  • University of California, San FranciscoRecruiting

    San Francisco, California, 94143 · United States

  • Cleveland Clinic Florida, Weston HospitalRecruiting

    Weston, Florida, 33331 · United States

    • Chakra Chaulagain, MD
  • Tufts Medical CenterRecruiting

    Boston, Massachusetts, 02111 · United States

  • Columbia University Irving Medical CenterRecruiting

    New York, New York, 10032 · United States

  • Memorial Sloan Kettering Cancer CenterRecruiting

    New York, New York, 10065 · United States

  • Atrium Health Levine Cancer InstituteRecruiting

    Charlotte, North Carolina, 28204 · United States

  • UNC Lineberger Comprehensive Cancer CenterRecruiting

    Durham, North Carolina, 27705 · United States

  • The Ohio State University Comprehensive Cancer CenterRecruiting

    Columbus, Ohio, 43210 · United States

    • Naresh Bumma, MD

Terms used on this page · explanations by MedicalUpdates.ai

standard of care
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
dFLC
The difference between the abnormal ('involved') and normal ('uninvolved') free light chain levels in the blood. Used in some conditions to decide whether disease is measurable and to track response.
FLC
Small pieces of antibody protein made by plasma cells and measured in a blood test. In some conditions, such as AL amyloidosis, abnormal free light chains are the source of the disease.
eGFR
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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