Screening to Improve Survival in AL Amyloidosis

Tufts University

Status: Completed

Conditions: Monoclonal Gammopathy of Undetermined Significance; Smoldering Multiple Myeloma

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04615572

00000858

1R21AG070502-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to see whether certain genes may be linked with the development of AL amyloidosis in subjects 60 years of age or older with the blood disorders SMM and MGUS. A limited repertoire of immunoglobulin (Ig) variable region genes have been associated with AL amyloidosis. The clonal plasma cells of subjects with SMM and MGUS may express one of these Ig variable region genes indicating a risk of progression to AL amyloidosis and potentially enabling early diagnosis. We hope this study will help us begin to understand whether Ig variable region gene identification can be a useful tool for assessing a subject's risk of progression to AL amyloidosis.

Enrollment: 35 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 60 years of age and older
• Diagnosed with λ LC MGUS or λ LC SMM
• dFLC greater than 23 mg/L and κ::λ free LC ratio below normal
• If the patient has an eGFR less than 50 mL/min/1.73m2, the κ::λ free LC ratio is inconsequential. The patient only needs to meet the age, dFLC, and λ LC MGUS or λ LC SMM diagnosis criteria in this case

Exclusion criteria

• Patients with κ LC MGUS or κ LC SMM
• Amyloid in the bone marrow or in other biopsies will not be included
• Patients younger than 60 years of age are not eligible