Isatuximab-Specific Immunofixation Electrophoresis Assay to Remove Interference in Serum M-Protein Measurement in Patients with Multiple Myeloma

被引:2
|
作者
Thoren, Katie [1 ,4 ]
Menad, Samia [2 ]
Nouadje, Georges [2 ]
Mace, Sandrine [3 ]
机构
[1] Mem Sloan Kettering Canc Ctr, New York, NY USA
[2] Sebia, Lisses, France
[3] Sanofi R&D, Chilly Mazarin, France
[4] Univ Miami, Dept Pathol, 1600 NW 10th Ave,RMSB 7166, Miami, FL 33136 USA
来源
JOURNAL OF APPLIED LABORATORY MEDICINE | 2024年
关键词
QUALITY-OF-LIFE; DARATUMUMAB; ANTIBODY; GUIDELINES; DISEASE; DRUG;
D O I
10.1093/jalm/jfae028
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
Background Isatuximab, an IgG-kappa (IgG kappa) anti-cluster of differentiation 38 (CD38) monoclonal antibody approved for use in patients with relapsed or refractory multiple myeloma (MM), can potentially interfere with the visualization of endogenous monoclonal protein (M-protein) on standard immunofixation electrophoresis (IFE) and lead to inaccurate classification of a patient's response to therapy. The Hydrashift 2/4 isatuximab IFE assay (Hydrashift isatuximab assay) removes isatuximab interference from IFE. Using samples from patients enrolled in clinical trials of isatuximab-based therapy for MM, we demonstrate how the Hydrashift isatuximab assay improves the ability to detect residual M-protein and offer recommendations for when the assay is most useful.Methods Samples from 141 patients with a variety of known M-protein isotypes were selected and analyzed by standard IFE and the Hydrashift isatuximab assay. A positive control containing isatuximab was run on every standard IFE and Hydrashift gel.Results The Hydrashift isatuximab assay reliably shifted the migration of isatuximab in patient samples. Standard IFE was adequate for determining 104 patients' M-protein status, and the Hydrashift isatuximab assay confirmed these results. In samples from 37 patients with a history of IgG kappa MM and a single IgG kappa band visible on standard IFE near the isatuximab migration site, the Hydrashift isatuximab assay was able to separate isatuximab from endogenous M-protein, identifying residual M-protein in 17 samples and preventing false-positive interpretations of standard IFE in 20 samples.Conclusions The Hydrashift isatuximab assay is most useful in patients with known IgG kappa MM when a single IgG kappa band appears near the isatuximab migration site on standard IFE during isatuximab-based therapy. ClinicalTrials.gov Registration Numbers: NCT03275285 and NCT03319667.
引用
收藏
页码:661 / 671
页数:11
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