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Quality assessment of autografting by probability evaluation: model estimation by clinical end-points in newly diagnosed multiple myeloma patients
Cytotherapy ( IF 3.7 ) Pub Date : 2006-01-01 , DOI: 10.1080/14653240500499549
O Roer 1 , J Hammerstrøm , S Lenhoff , A K Mylin , L M Knudsen , T Rasmussen , H E Johnsen ,
Affiliation  

BACKGROUND Pre-transplant clinical evaluation of autografting is an important step in predicting post-transplant support, complications and safety. Today, unfavorable outcomes such as early death or graft failure are rare, making them unsuitable for quality assessment of supportive autografting. However, end-points constructed from frequently occurring clinical events may estimate clinically relevant prognostic models. METHODS The present retrospective analysis was based on two consecutive clinical trials in the Nordic area including up to 640 newly diagnosed multiple myeloma patients. RESULTS In the model, the efficacy (time on antibiotics and use of transfusions) was influenced by pre-transplant variables, including sex, nationality, serum creatinine, hemoglobin, disease stage at diagnosis, response following induction therapy, length of priming and average graft CD34+ cell number per day of harvest. The toxicity end-point (time to blood cell recovery) was influenced by nationality, marrow plasma cell percentage, serum creatinine, M-component isotype, response to induction therapy, length of priming and graft CD34+ cell number. The safety (early disease recurrence or death) was influenced by serum creatinine, hemoglobin, treatment response and CD34+ cell number. DISCUSSION In conclusion, the model illustrates that intervention strategies in quality assessment of autografting may benefit from probability estimates of graded clinical end-points.

中文翻译:

通过概率评估对自体移植的质量评估:新诊断多发性骨髓瘤患者临床终点的模型估计

背景自体移植的移植前临床评估是预测移植后支持、并发症和安全性的重要步骤。如今,早期死亡或移植失败等不利结果很少见,因此不适用于支持性自体移植的质量评估。然而,从频繁发生的临床事件构建的终点可以估计临床相关的预后模型。方法 本回顾性分析基于北欧地区的两项连续临床试验,包括多达 640 名新诊断的多发性骨髓瘤患者。结果 在模型中,疗效(抗生素使用时间和输血使用)受移植前变量的影响,包括性别、国籍、血清肌酐、血红蛋白、诊断时的疾病分期、诱导治疗后的反应、每天收获的引发时间和平均移植 CD34+ 细胞数。毒性终点(血细胞恢复时间)受国籍、骨髓浆细胞百分比、血清肌酐、M 成分同种型、对诱导治疗的反应、启动时间和移植 CD34+ 细胞数的影响。安全性(早期疾病复发或死亡)受血清肌酐、血红蛋白、治疗反应和 CD34+ 细胞数量的影响。讨论 总之,该模型说明了自体移植质量评估中的干预策略可能受益于分级临床终点的概率估计。对诱导治疗的反应、启动时间和移植 CD34+ 细胞数。安全性(早期疾病复发或死亡)受血清肌酐、血红蛋白、治疗反应和 CD34+ 细胞数量的影响。讨论 总之,该模型说明了自体移植质量评估中的干预策略可能受益于分级临床终点的概率估计。对诱导治疗的反应、启动时间和移植 CD34+ 细胞数。安全性(早期疾病复发或死亡)受血清肌酐、血红蛋白、治疗反应和 CD34+ 细胞数量的影响。讨论 总之,该模型说明了自体移植质量评估中的干预策略可能受益于分级临床终点的概率估计。
更新日期:2006-01-01
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