Achievement of a complete response (CR) in multiple myeloma (MM) correlates with improvement in survival outcomes; however, its impact on prognostic variables at baseline outside of clinical trial settings is not well described. We sought to determine the impact of achieving a CR within 2 years from diagnosis, its effect on the prognostic value of fluorescence in situ hybridization (FISH) and International Staging System (ISS) risk, and examined additional predictors of outcome among those achieving a CR in a routine clinical setting. We evaluated 1869 newly diagnosed MM patients who had ≥ 2 monoclonal protein immunofixation studies in the serum and urine available within 24 months from diagnosis, categorizing those with ≥ 2 negative serum and urine immunofixations as achieving CR. With a landmark at 24 months, median progression-free survival (PFS) for CR versus non-CR patients was 29.8 versus 20.9 months (p ≤ .0002); median overall survival (OS) was 104 versus 70 months (p < .0001). The impact of achieving a CR was retained after adjusting for FISH, ISS, sex, transplant status, and involved heavy chain. Baseline FISH and ISS stage were not associated with PFS or OS among patients achieving a CR. The following variables were found as predictors of inferior OS within the CR cohort: age > 75 years, male gender, hypoalbuminemia, and non-immunoglobulin G involved heavy chain. Our study confirms that achievement of CR within 2 years from diagnosis is associated with improvement in survival outcomes and neutralization of the impact of FISH and ISS risk, thereby confirming observations from the clinical trial setting among a clinical practice cohort.

中文翻译：

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对多发性骨髓瘤初始治疗实现完全反应的影响和后续结果的预测因素

在多发性骨髓瘤 (MM) 中实现完全缓解 (CR) 与生存结果的改善相关；然而，它对临床试验设置之外的基线预后变量的影响没有得到很好的描述。我们试图确定在诊断后 2 年内实现 CR 的影响，其对荧光原位杂交 (FISH) 和国际分期系统 (ISS) 风险的预后价值的影响，并检查了那些实现 CR 的结果的其他预测因素在常规临床环境中。我们评估了 1869 名新诊断的 MM 患者，这些患者在诊断后 24 个月内对血清和尿液进行了≥2 次单克隆蛋白免疫固定研究，将血清和尿液免疫固定≥2 次阴性的患者归类为达到 CR。在 24 个月时具有里程碑意义，p  ≤ .0002)；中位总生存期 (OS) 分别为 104 个月和 70 个月 ( p  < .0001)。在调整 FISH、ISS、性别、移植状态和涉及重链后，实现 CR 的影响得以保留。在达到 CR 的患者中，基线 FISH 和 ISS 分期与 PFS 或 OS 无关。发现以下变量可作为 CR 队列中劣 OS 的预测因素：年龄 > 75 岁、男性、低白蛋白血症和非免疫球蛋白 G 涉及重链。我们的研究证实，在诊断后 2 年内实现 CR 与生存结果的改善和 FISH 和 ISS 风险影响的中和有关，从而证实了临床实践队列中临床试验设置的观察结果。