Summary

Eligibility
for people ages 60 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Sandy Wong, MD
Headshot of Sandy Wong
Sandy Wong

Description

Summary

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.

Keywords

Smoldering Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance, SMM, MGUS, AL Amyloidosis, Multiple Myeloma, Immunoglobulin Light-chain Amyloidosis, Paraproteinemias, Amyloidosis

Eligibility

You can join if…

Open to people ages 60 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • University of California, Irvine Health Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States

Lead Scientist at UCSF

  • Sandy Wong, MD
    Assistant Professor, Medicine, School of Medicine. Authored (or co-authored) 88 research publications. Research interests: amyloidosis · plasma cell dyscrasias · multiple myeloma · MGUS · SMM

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Tufts Medical Center
ID
NCT04615572
Study Type
Observational
Participants
Expecting 50 study participants
Last Updated