Screening for AL Amyloidosis in patients with Smoldering Multiple Myeloma

Screening for AL Amyloidosis in Smoldering Multiple Myeloma

This study is trying to find out if screening for a specific type of amyloidosis can help catch it early in patients with smoldering multiple myeloma before they show any symptoms.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Tufts Medical Center (other)
• Locations: 13 sites (Birmingham, Alabama and 12 other locations)
• Trial ID: NCT06365060 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 40 years or older with a diagnosis of smoldering multiple myeloma and specific FLC abnormalities.

Not a fit: Patients younger than 40 years or those with a previous diagnosis of amyloid in other biopsies will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier diagnosis and intervention for patients at risk of developing AL, potentially improving outcomes.

How similar studies have performed: Previous studies have indicated that screening for AL in patients with SMM may be beneficial, suggesting potential success for this approach.

Eligibility criteria

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 this trial is running

Birmingham, Alabama and 12 other locations

• 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)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
• Atrium Health Levine Cancer Institute — Charlotte, North Carolina, United States (RECRUITING)
• UNC Lineberger Comprehensive Cancer Center — Durham, North Carolina, United States (RECRUITING)
• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (RECRUITING)
• UT Southwestern, Harold C. Simmons Comprehensive Cancer Center — Dallas, Texas, United States (NOT_YET_RECRUITING)
• University of Utah, Huntsman Cancer Hospital — Salt Lake City, Utah, United States (RECRUITING)
• VCU Medical Center — Richmond, Virginia, United States (RECRUITING)

Study contacts

• Study coordinator: Raymond Comenzo, MD

Conditions: Smoldering Multiple Myeloma, SMM, AL Amyloidosis