OBJECTIVES Multiple myeloma (MM) is characterized by malignant growth of plasma cells, usually producing a monoclonal antibody (mAb). New treatments for MM include therapeutic monoclonal antibodies (tmAbs), but patients treated with tmAb demonstrate interference on serum electrophoresis (SPE) and immunoprecipitation electrophoresis (IEP). Evaluation of treatment efficacy and determination of MM remission include SPE and IEP which identifies mAb, but cannot differentiate between disease associated mAb and tmAb. We hypothesized that tmAb could be removed from patient sera before testing by SPE and IEP to provide accurate diagnoses for clinicians. DESIGN AND METHODS We developed the Antigen Specific therapeutic monoclonal Antibody Depletion Assay (ASADA), that utilizes magnetic beads coated with the cognate antigen of the tmAbs, to deplete two different tmAb (daratumumab, elotuzumab) from saline and patient sera and assessed for complete removal of tmAb by SPE and IEP. RESULTS We found that tmAb could be efficiently removed from saline and patient sera. ASADA demonstrated acceptable analytical specificity and sensitivity in IEP. Recovery of appropriate quantitative values by SPE was demonstrated with clinically acceptable precision. A single bead cocktail could be used to treat both daratumumab and elotuzumab. CONCLUSIONS This demonstrates proof of principle that ASADA can be used to remove current and future tmAb from patient sera, regardless of platform. This research provides for accurate diagnosis, disease monitoring, and remission status in MM patients being treated with tmAb.

中文翻译：

---

一种消除治疗性单克隆抗体对血清蛋白电泳干扰的新方法。

目的 多发性骨髓瘤 (MM) 的特点是浆细胞恶性生长，通常产生单克隆抗体 (mAb)。MM 的新疗法包括治疗性单克隆抗体 (tmAb)，但接受 tmAb 治疗的患者表现出对血清电泳 (SPE) 和免疫沉淀电泳 (IEP) 的干扰。治疗效果评估和 MM 缓解确定包括 SPE 和 IEP，可识别 mAb，但无法区分疾病相关 mAb 和 tmAb。我们假设在 SPE 和 IEP 检测之前可以从患者血清中去除 tmAb，为临床医生提供准确的诊断。设计和方法 我们开发了抗原特异性治疗性单克隆抗体消除测定 (ASADA)，它利用涂有 tmAb 同源抗原的磁珠，从盐水和患者血清中消除两种不同的 tmAb（daratumumab、elotuzumab），并评估是否完全去除通过 SPE 和 IEP 检测 tmAb。结果我们发现 tmAb 可以有效地从盐水和患者血清中去除。ASADA 在 IEP 中表现出可接受的分析特异性和敏感性。通过 SPE 可以恢复适当的定量值，其精确度符合临床要求。单珠鸡尾酒可用于治疗达雷妥尤单抗和埃洛妥珠单抗。结论 这证明了 ASADA 可用于从患者血清中去除当前和未来的 tmAb，无论平台如何。这项研究为接受 tmAb 治疗的 MM 患者提供了准确的诊断、疾病监测和缓解状态。