Screening to Improve Survival in AL Amyloidosis

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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

Trial contacts and locations

0

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Central trial contact

Raymond Comenzo, MD; Denis Toskic, BS

Data sourced from clinicaltrials.gov

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