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A Diagnostic Screening Trial Seeking AL Amyloidosis Very Early

NCT02741999 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2020-05-11

No results posted yet for this study

Summary

This protocol seeks to enroll smoldering multiple myeloma (SMM) and monoclonal gammopathy of undetermined significant (MGUS) patients with λ light chain (LC) involvement, a group of patients for whom standard of care is observation not treatment. Patients with SMM and MGUS have a precursor plasma cell disorder from which light chain amyloidosis (AL) can evolve. In this trial, enrolled subjects will have blood and if available bone marrow cells evaluated by molecular testing to determine their clonal λ LC variable region (VL) germline gene. Seventy percent of AL cases involve just 7 germline donors, 5 of which are λ germline donors. The hypothesis that will be tested with this protocol is that the presence of AL germline genes associated with AL in patients with a pre-existing diagnosis of λ SMM or λ MGUS indicates the presence of AL or risk of progression to AL.

Conditions

  • Plasma Cell Dyscrasia
  • Monoclonal Gammopathy

Sponsors & Collaborators

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Raymond Comenzo, MD · Tufts Medical Center

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2020-04-05
Completion
2020-04-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02741999 on ClinicalTrials.gov