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Iceland screens, treats, or prevents multiple myeloma (iStopMM): a population-based screening study for monoclonal gammopathy of undetermined significance and randomized controlled trial of follow-up strategies
Blood Cancer Journal ( IF 12.8 ) Pub Date : 2021-05-17 , DOI: 10.1038/s41408-021-00480-w
Sæmundur Rögnvaldsson 1 , Thorvardur Jon Love 1 , Sigrun Thorsteinsdottir 1, 2 , Elín Ruth Reed 1 , Jón Þórir Óskarsson 1 , Íris Pétursdóttir 1 , Guðrún Ásta Sigurðardóttir 1 , Brynjar Viðarsson 3 , Páll Torfi Önundarson 1, 3 , Bjarni A Agnarsson 1, 3 , Margrét Sigurðardóttir 3 , Ingunn Þorsteinsdóttir 3 , Ísleifur Ólafsson 3 , Ásdís Rósa Þórðardóttir 1 , Elías Eyþórsson 3 , Ásbjörn Jónsson 3 , Andri S Björnsson 4 , Gunnar Þór Gunnarsson 1, 5 , Runólfur Pálsson 1, 3 , Ólafur Skúli Indriðason 1, 3 , Gauti Kjartan Gíslason 1 , Andri Ólafsson 1 , Guðlaug Katrín Hákonardóttir 1 , Manje Brinkhuis 1 , Sara Lovísa Halldórsdóttir 1 , Tinna Laufey Ásgeirsdóttir 6 , Hlíf Steingrímsdóttir 3 , Ragnar Danielsen 3 , Inga Dröfn Wessman 4 , Petros Kampanis 7 , Malin Hultcrantz 8 , Brian G M Durie 9 , Stephen Harding 7 , Ola Landgren 10 , Sigurður Yngvi Kristinsson 1, 3
Affiliation  

Monoclonal gammopathy of undetermined significance (MGUS) precedes multiple myeloma (MM). Population-based screening for MGUS could identify candidates for early treatment in MM. Here we describe the Iceland Screens, Treats, or Prevents Multiple Myeloma study (iStopMM), the first population-based screening study for MGUS including a randomized trial of follow-up strategies. Icelandic residents born before 1976 were offered participation. Blood samples are collected alongside blood sampling in the Icelandic healthcare system. Participants with MGUS are randomized to three study arms. Arm 1 is not contacted, arm 2 follows current guidelines, and arm 3 follows a more intensive strategy. Participants who progress are offered early treatment. Samples are collected longitudinally from arms 2 and 3 for the study biobank. All participants repeatedly answer questionnaires on various exposures and outcomes including quality of life and psychiatric health. National registries on health are cross-linked to all participants. Of the 148,704 individuals in the target population, 80 759 (54.3%) provided informed consent for participation. With a very high participation rate, the data from the iStopMM study will answer important questions on MGUS, including potentials harms and benefits of screening. The study can lead to a paradigm shift in MM therapy towards screening and early therapy.



中文翻译:

冰岛筛查、治疗或预防多发性骨髓瘤 (iStopMM):一项基于人群的意义未明的单克隆丙种球蛋白病筛查研究和随访策略的随机对照试验

意义未明的单克隆丙种球蛋白病 (MGUS) 先于多发性骨髓瘤 (MM)。基于人群的 MGUS 筛查可以确定 MM 早期治疗的候选者。在这里,我们描述了冰岛筛查、治疗或预防多发性骨髓瘤研究 (iStopMM),这是第一个基于人群的 MGUS 筛查研究,包括随访策略的随机试验。1976 年之前出生的冰岛居民可以参与。在冰岛的医疗保健系统中,血液样本与血液样本一起收集。患有 MGUS 的参与者被随机分配到三个研究组。第 1 组未接触,第 2 组遵循当前指南,第 3 组遵循更密集的策略。为取得进展的参与者提供早期治疗。从第 2 和第 3 臂纵向收集样品用于研究生物库。所有参与者都反复回答有关各种暴露和结果的问卷,包括生活质量和精神健康。国家健康登记册与所有参与者交叉链接。在目标人群的 148,704 人中,80,759 (54.3%) 人提供了参与的知情同意书。由于参与率非常高,iStopMM 研究的数据将回答有关 MGUS 的重要问题,包括筛查的潜在危害和益处。该研究可能导致 MM 治疗向筛查和早期治疗的范式转变。由于参与率非常高,iStopMM 研究的数据将回答有关 MGUS 的重要问题,包括筛查的潜在危害和益处。该研究可能导致 MM 治疗向筛查和早期治疗的范式转变。由于参与率非常高,iStopMM 研究的数据将回答有关 MGUS 的重要问题,包括筛查的潜在危害和益处。该研究可能导致 MM 治疗向筛查和早期治疗的范式转变。

更新日期:2021-05-17
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