Laboratory diagnostic in multiple myeloma: Quantification of daratumumab blood levels using isoelectric focusing.

IF 2.9 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2025-10-07 DOI:10.1016/j.cca.2025.120650

Rieke Reiter, Christoph Mann, Wolfgang Andreas Nockher

{"title":"Laboratory diagnostic in multiple myeloma: Quantification of daratumumab blood levels using isoelectric focusing.","authors":"Rieke Reiter, Christoph Mann, Wolfgang Andreas Nockher","doi":"10.1016/j.cca.2025.120650","DOIUrl":null,"url":null,"abstract":"Objectives: Therapeutic monoclonal antibodies (tmAbs) such as daratumumab (DmAb) are among the primary treatment options for multiple myeloma. The availability of immunoassays for measuring tmAb blood levels is limited, although determining antibody concentrations may be of interest in cases of unexpected clinical outcomes. As has previously been demonstrated, isoelectric focusing (IEF) can be used to identify tmAbs and their differentiation from paraproteins. Here, the use of IEF for measuring tmAb concentrations is further expanded.Methods: First, a DmAb standard series ranging from 2.5 to 0.08 mg/L spiked with a polyclonal IgG background of 2.5 mg/L was defined and evaluated. After establishing the standard series, the DmAb concentrations were analyzed in patient blood samples collected one to five weeks post-administration, depending on the time after administration and the corresponding therapy phase.Results: DmAb concentrations stabilized three to four weeks after administration. Within a therapy cycle, profound differences in DmAb levels were observed when comparing the induction, consolidation and maintenance phase.Conclusion: IEF is a suitable tool for evaluating blood concentrations of DmAb and possibly other tmAbs in case of challenging therapy response.","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120650"},"PeriodicalIF":2.9000,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinica Chimica Acta","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.cca.2025.120650","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Objectives: Therapeutic monoclonal antibodies (tmAbs) such as daratumumab (DmAb) are among the primary treatment options for multiple myeloma. The availability of immunoassays for measuring tmAb blood levels is limited, although determining antibody concentrations may be of interest in cases of unexpected clinical outcomes. As has previously been demonstrated, isoelectric focusing (IEF) can be used to identify tmAbs and their differentiation from paraproteins. Here, the use of IEF for measuring tmAb concentrations is further expanded.

Methods: First, a DmAb standard series ranging from 2.5 to 0.08 mg/L spiked with a polyclonal IgG background of 2.5 mg/L was defined and evaluated. After establishing the standard series, the DmAb concentrations were analyzed in patient blood samples collected one to five weeks post-administration, depending on the time after administration and the corresponding therapy phase.

Results: DmAb concentrations stabilized three to four weeks after administration. Within a therapy cycle, profound differences in DmAb levels were observed when comparing the induction, consolidation and maintenance phase.

Conclusion: IEF is a suitable tool for evaluating blood concentrations of DmAb and possibly other tmAbs in case of challenging therapy response.

查看原文本刊更多论文

多发性骨髓瘤的实验室诊断：使用等电聚焦定量daratumumab血液水平。

目的：治疗性单克隆抗体（tmab）如达拉单抗（DmAb）是多发性骨髓瘤的主要治疗选择之一。尽管确定抗体浓度可能对意外临床结果的病例感兴趣，但用于测量tmAb血液水平的免疫测定的可用性是有限的。如前所述，等电聚焦（IEF）可用于识别单克隆抗体及其与副蛋白的分化。在这里，IEF用于测量tmAb浓度的使用得到了进一步扩展。方法：首先，定义和评估范围为2.5 - 0.08 mg/L、多克隆IgG背景为2.5 mg/L的DmAb标准系列。建立标准系列后，根据给药后的时间和相应的治疗阶段，分析给药后1至5周收集的患者血液样本中的DmAb浓度。结果：给药后3 - 4周，DmAb浓度稳定。在一个治疗周期内，当比较诱导、巩固和维持阶段时，观察到DmAb水平的深刻差异。结论：IEF是一种评估DmAb血药浓度的合适工具，在治疗反应具有挑战性的情况下，也可能是其他tmab血药浓度的评估工具。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Clinica Chimica Acta 医学-医学实验技术

CiteScore

10.10

自引率

2.00%

发文量

1268

审稿时长

23 days

期刊介绍： The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells. The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.