Diagnosis and monitoring for light chain only and oligosecretory myeloma using serum free light chain tests

Br J Haematol. 2017 Jul;178(2):220-230. doi: 10.1111/bjh.14753. Epub 2017 Jun 1.

Abstract

This study aims to guide the integration of serum free light chain (sFLC) tests into clinical practice, including a new rapid test (Seralite® ). Blood and urine analysis from 5573 newly diagnosed myeloma patients identified 576 light chain only (LCO) and 60 non-secretory (NS) cases. Serum was tested by Freelite® and Seralite® at diagnosis, maximum response and relapse. 20% of LCO patients had urine FLC levels below that recommended for measuring response but >97% of these had adequate sFLC levels (oligosecretory). The recommended Freelite® sFLC ≥100 mg/l for measuring response was confirmed and the equivalent Seralite® FLC difference (dFLC) >20 mg/l identified. By both methods, ≥38% of NS patients had measurable disease (oligosecretory). Higher sFLC levels were observed on Freelite® at all time points. However, good clinical concordance was observed at diagnosis and in response to therapy. Achieving at least a very good partial response according to either sFLC method was associated with better patient survival. Relapse was identified using a Freelite® sFLC increase >200 mg/l and found 100% concordance with a corresponding Seralite® dFLC increase >30 mg/l. Both Freelite® and Seralite® sensitively diagnose and monitor LCO/oligosecretory myeloma. Rapid testing by Seralite® could fast-track FLC screening and monitoring. Response by sFLC assessment was prognostic for survival and demonstrates the clinical value of routine sFLC testing.

Keywords: free light chains; multiple myeloma; non-secretory; quantitation; serum; survival.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aftercare
  • Disease-Free Survival
  • Humans
  • Immunoassay / methods
  • Immunoglobulin Light Chains / metabolism
  • Immunoglobulins / metabolism
  • Multiple Myeloma / diagnosis*
  • Multiple Myeloma / immunology
  • Multiple Myeloma / mortality
  • Neoplasm Recurrence, Local / diagnosis
  • Neoplasm Recurrence, Local / immunology
  • Neoplasm Recurrence, Local / mortality
  • Point-of-Care Systems
  • Retrospective Studies
  • Sensitivity and Specificity

Substances

  • Immunoglobulin Light Chains
  • Immunoglobulins
  • M-proteins (Myeloma)