Multiple Myeloma Clinical Trial

Screening to Improve Survival in AL Amyloidosis

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

35

Study ID:

NCT04615572

Recruitment Status:

Completed

Sponsor:

Tufts Medical Center

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There are 6 Locations for this study

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University of California, Irvine Health Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
University of California, San Francisco
San Francisco California, 94143, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
Columbia University Irving Medical Center
New York New York, 10032, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

35

Study ID:

NCT04615572

Recruitment Status:

Completed

Sponsor:


Tufts Medical Center

How clear is this clinincal trial information?

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