Rifkin Robert M, Abonour Rafat, Terebelo Howard, Shah Jatin J, Gasparetto Cristina, Hardin James, Srinivasan Shankar, Ricafort Rosanna, Nagarwala Yasir, Durie Brian G M
US Oncology Research, The Woodlands, TX and Rocky Mountain Cancer Centers, Denver, CO.
Indiana University Simon Cancer Center, Indianapolis, IN.
Clin Lymphoma Myeloma Leuk. 2015 Jun;15(6):368-76. doi: 10.1016/j.clml.2014.12.002. Epub 2014 Dec 11.
Connect MM is the first and largest observational, noninterventional, prospective registry of patients newly diagnosed with multiple myeloma (NDMM) in the United States. It collects longitudinal data on patients within clinical practice including patients in clinical trials.
Of the 1513 patients enrolled, 1493 were protocol-eligible.
Median age was 67 years, 81.9% (1223/1493) were Caucasian, and 57.2% (854/1493) were male. Of these patients, 26.5% (232/877) were International Staging System stage I, 34.9% (306/877) stage II, and 38.7% (339/877) stage III. Eastern Cooperative Oncology Group performance status of 0/1/2 were reported in 96.6% (1017/1053). Clonal plasma cells > 10% were found in 91.6% (1282/1399) of patients and M-component in 98.8% (1343/1359). Hypercalcemia was present in 7.3% (108/1481) of patients, serum creatinine > 2 mg/dL in 18.3% (271/1484), anemia in 45.1% (673/1493), and bone involvement in 76.7% (1143/1490). Of the 15 National Comprehensive Cancer Network (NCCN) recommended diagnostic tests, a median of 12 were performed. Lactate dehydrogenase assessment, serum free light chain ratio, and immunofixation were reported in 38.4% (574/1493), 62.1% (927/1493), and 66% (985/1493) of patients, respectively. Quantitative immunoglobulin, β-2 microglobulin, and protein electrophoresis (serum or urine) were reported in 72.3% (1080/1493), 74.1% (1107/1493), and 78.0% (1164/1493) of patients, respectively. Bone marrow biopsy was reported in 92.2% (1376/1493), but conventional cytogenetic and fluorescence in situ hybridization analysis were reported in only 63.2% (944/1493) and 59.8% (893/1493) of patients, respectively. A high-risk cytogenetic profile (according to International Myeloma Working Group [IMWG] criteria) was found in 16.9% (253/1493).
This analysis provides insight into the demographic and disease characteristics of NDMM patients in a range of clinical practices. Creating solid records of baseline patient disease characteristics using suggested NCCN diagnostic work-up and IMWG criteria provides a foundation for monitoring disease progression and response to treatment.
Connect MM是美国首个也是规模最大的针对新诊断的多发性骨髓瘤（NDMM）患者的观察性、非干预性前瞻性登记研究。它收集临床实践中患者的纵向数据，包括参加临床试验的患者。
在1513名登记患者中，1493名符合方案要求。
中位年龄为67岁，81.9%（1223/1493）为白种人，57.2%（854/1493）为男性。这些患者中，26.5%（232/877）为国际分期系统I期，34.9%（306/877）为II期，38.7%（339/877）为III期。东部肿瘤协作组体能状态为0/1/2的患者占96.6%（1017/1053）。91.6%（1282/1399）的患者克隆性浆细胞>10%，98.8%（1343/1359）的患者存在M蛋白成分。7.3%（108/1481）的患者有高钙血症，18.3%（271/1484）的患者血清肌酐>2mg/dL，45.1%（673/1493）的患者有贫血，76.7%（1143/1490）的患者有骨受累。在15项美国国立综合癌症网络（NCCN）推荐的诊断检查中，中位检查项目数为12项。分别有38.4%（574/1493）、62.1%（927/1493）和66%（985/1493）的患者进行了乳酸脱氢酶评估、血清游离轻链比值检测和免疫固定电泳。分别有72.3%（1080/1493）、74.1%（1107/1493）和78.0%（1164/1493）的患者进行了定量免疫球蛋白、β2微球蛋白和蛋白电泳（血清或尿液）检测。92.2%（1376/1493）的患者进行了骨髓活检，但分别只有63.2%（944/1493）和59.8%（893/1493）的患者进行了传统细胞遗传学和荧光原位杂交分析。16.9%（253/1493）的患者具有高危细胞遗传学特征（根据国际骨髓瘤工作组[IMWG]标准）。
该分析深入了解了一系列临床实践中NDMM患者的人口统计学和疾病特征。使用NCCN建议的诊断检查流程和IMWG标准创建患者基线疾病特征的可靠记录，为监测疾病进展和治疗反应奠定了基础。
