Screening for AL Amyloidosis in patients with Smoldering Multiple Myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study aims to recruit 400 patients aged 40 and older diagnosed with smoldering multiple myeloma (SMM) to screen for light-chain amyloidosis (AL) before symptoms develop. The study will investigate specific biomarkers and genetic abnormalities associated with AL to develop a likelihood algorithm for early diagnosis. By analyzing factors such as free light chain (FLC) abnormalities and cytogenetic changes, the study seeks to identify patients at risk for progression to AL. The findings could enhance early detection and management strategies for this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama Hospital
  Birmingham, Alabama, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting
• Cleveland Clinic Florida, Weston Hospital
  Weston, Florida, United States Recruiting
• Tufts Medical Center
  Boston, Massachusetts, United States Recruiting
• Columbia University Irving Medical Center
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Raymond Comenzo, MD
• Email: raymond.comenzo@tuftsmedicine.org
• Phone: 617-636-6454

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.