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Time to Revise Myeloma Diagnostic Criteria? A Decade of Accumulated Evidence on Serum Free Light Chain Ratio ≥100. 是时候修订骨髓瘤诊断标准了？血清游离轻链比≥100的十年积累证据

IF 20.3 1区医学 Q1 HEMATOLOGY

Blood

Pub Date : 2026-01-20 DOI: 10.1182/blood.2025031907

Rajshekhar Chakraborty,Ghulam Rehman Mohyuddin

In 2014, the International Myeloma Working Group (IMWG) expanded multiple myeloma diagnostic criteria to include serum free light chain (sFLC) ratio ≥100 as a standalone myeloma-defining biomarker based on studies suggesting approximately 80% risk of progression to overt myeloma at 2 years. However, subsequent studies demonstrate a substantially lower risk of progression, with a population-based registry data showing 2-year risk as low as 30.4% in this group. Importantly, subsequent data showed that over 70% of patients with sFLC ratio ≥100 have 24-hour monoclonal proteinuria <200 mg-a subgroup with particularly low progression risk (13.5% at 2 years) and minimal risk of irreversible renal failure. Furthermore, with the IMWG diagnostic amendment, sFLC ratio ≥100 is currently included within the composite endpoint of progression-free survival in early intervention clinical trials of high-risk smoldering multiple myeloma, which poses a risk of misclassifying biochemical changes as clinically meaningful events. We propose immediate revision of the diagnostic criteria to remove sFLC ratio ≥100 as standalone myeloma-defining event and exclusion of patients with sFLC ratio ≥100 from trials of newly diagnosed myeloma. These patients should be included in prospective studies on therapeutic interventions in high-risk smoldering myeloma as well as active surveillance with modern imaging to define their natural history in the contemporary era.

2014年，国际骨髓瘤工作组（IMWG）扩大了多发性骨髓瘤的诊断标准，将血清游离轻链（sFLC）比率≥100作为单独的骨髓瘤定义生物标志物，基于研究表明，2年进展为显性骨髓瘤的风险约为80%。然而，随后的研究显示进展风险大大降低，基于人群的登记数据显示该组2年风险低至30.4%。重要的是，随后的数据显示，超过70%的sFLC比率≥100的患者24小时单克隆蛋白尿<200 mg-a亚组的进展风险特别低（2年时为13.5%），不可逆肾功能衰竭的风险最小。此外，随着IMWG诊断修订，sFLC比率≥100目前被纳入高风险阴燃型多发性骨髓瘤早期干预临床试验的无进展生存的复合终点，这有将生化变化错误分类为临床有意义事件的风险。我们建议立即修订诊断标准，将sFLC比率≥100作为单独的骨髓瘤定义事件，并将sFLC比率≥100的患者排除在新诊断的骨髓瘤试验之外。这些患者应纳入高风险阴燃骨髓瘤治疗干预措施的前瞻性研究，以及现代影像学的积极监测，以确定其在当代的自然历史。

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引用次数: 0

Global access to commercial CAR T cells: A cross-sectional study of health technology assessment in the G20. 全球获得商业化CAR - T细胞：20国集团卫生技术评估的横断面研究

IF 20.3 1区医学 Q1 HEMATOLOGY

Blood

Pub Date : 2026-01-16 DOI: 10.1182/blood.2025030872

Alex Y Ge,William B Feldman,Martin F Kaiser,Kai Rejeski,Gloria Iacoboni,Gaurav Narula,Jason Yongsheng Chan,Michael Dickinson,Aaron S Kesselheim,Edward Robert Scheffer Cliff

Chimeric antigen receptor T-cells (CAR T) are a major treatment advance for many patients with haematological malignancies, especially those with disease that has relapsed or is refractory to chemotherapy. However, currently approved commercial CAR T-cells require highly specialised manufacturing processes that contribute to high costs and limit their widespread use. In many countries, positive reimbursement recommendations by health technology assessment (HTA) bodies enable patient access to CAR T therapies. We performed a cross-sectional analysis of HTA evaluations of commercial CAR T therapies among G20 member countries plus three G20 invitees (Spain, Singapore, Switzerland) through 1 August 2025. Across the 18 CAR T-cell product-indication pairs with current FDA approval, we analysed HTA review documentation to ascertain the timing and rationale for a positive or negative recommendation. Fourteen countries with public HTA data were included in our analysis. Forty-eight percent of CAR T-indication pairs (122/252) are currently recommended for reimbursement by public health systems. The median time from FDA approval to HTA decision was 1·54 years (interquartile range 1·15-2·59 years). Common barriers to CAR T cost-effectiveness cited in HTA reports included single-arm trial designs, small study populations, and immature data regarding survival, safety, and quality of life. Our findings demonstrate substantial global disparities in access to CAR T treatments even among high- and upper middle-income countries, highlighting the urgent need for both scientific and policy approaches to reduce costs and improve access to these impactful therapies.

嵌合抗原受体T细胞（CAR - T）是许多血液系统恶性肿瘤患者的主要治疗进展，特别是那些复发或化疗难治的患者。然而，目前批准的商业CAR - t细胞需要高度专业化的制造工艺，这导致成本高，限制了它们的广泛使用。在许多国家，卫生技术评估机构提出的积极报销建议使患者能够获得CAR - T疗法。我们对G20成员国和三个G20受邀国（西班牙、新加坡、瑞士）在2025年8月1日之前对商业化CAR - T疗法的HTA评估进行了横断面分析。在目前FDA批准的18个CAR - t细胞产品适应症中，我们分析了HTA审查文件，以确定正面或负面推荐的时间和理由。我们的分析包括14个拥有公共HTA数据的国家。48%的CAR - t适应症配对（122/252）目前被公共卫生系统推荐报销。从FDA批准到HTA决定的中位时间为1.54年（四分位数间距为1.15 - 2.59年）。HTA报告中提到的CAR - T成本效益的常见障碍包括单臂试验设计、小研究人群以及关于生存、安全性和生活质量的不成熟数据。我们的研究结果表明，即使在高收入和中高收入国家，在获得CAR - T治疗方面也存在巨大的全球差异，这突出表明迫切需要科学和政策方法来降低成本并改善这些有效疗法的可及性。

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引用次数: 0

A small step yet one giant leap for cGVHD biomarkers. 对于cGVHD生物标志物来说，这是一小步，却是一大步。

IF 20.3 1区医学 Q1 HEMATOLOGY

Blood

Pub Date : 2026-01-15 DOI: 10.1182/blood.2025031596

Igor Novitzky-Basso,Dennis Dong Hwan Kim

引用次数: 0

miR-aculous effects for hemophilic arthropathy. mir对血友病关节病的急性效应。

IF 23.1 1区医学 Q1 HEMATOLOGY

Blood

Pub Date : 2026-01-15 DOI: 10.1182/blood.2025030987

Laurent O Mosnier

引用次数: 0

PU.1-Activated Genomic Regions Define Low-risk MDS Subsets Characterized by Immune Dysregulation and Disease Progression. pu1激活的基因组区域定义了以免疫失调和疾病进展为特征的低风险MDS亚群。

IF 20.3 1区医学 Q1 HEMATOLOGY

Blood

Pub Date : 2026-01-15 DOI: 10.1182/blood.2025030760

Veronica Vallelonga,Francesco Gandolfi,Matteo Zampini,Elena Riva,Giulia Maggioni,Denise Ventura,Elena Saba,Alberto Termanini,Sara Polletti,Elena Prosperini,Laura Crisafulli,Alessia Campagna,Ivan Ferrari,Nicole Pinocchio,Gabriele Todisco,Silvia Pedretti,Michela Calvi,Clara Di Vito,Domenico Mavilio,Nico Mitro,Francesca Ficara,Matteo G Della Porta,Serena Maria Luisa Ghisletti

Myelodysplastic syndromes (MDS) are heterogeneous myeloid neoplasms with an increased risk of progression to secondary acute myeloid leukemia (sAML). This study investigates the genomic correlates of disease progression in MDS by profiling active genomic regulatory regions and their transcriptional impact through H3K27ac ChIP-seq and RNA-seq analysis on CD34+ bone marrow progenitors cells isolated from a prospective cohort of 86 and 357 patients, respectively. Our analysis revealed distinct patterns of genomic region activation and transcriptional regulation across different disease stages (low-risk MDS, high-risk MDS and sAML). Unexpectedly, unsupervised clustering revealed a subset of low-risk MDS patients displaying regulatory and transcriptional profiles similar to those of high-risk MDS and sAML, highlighting early molecular events that may predispose patients to disease progression. This subset is characterized by PU.1 genomic occupancy in regions linked to immune and inflammatory responses, increased T-cell and NK activation, and a higher frequency of SRSF2 mutations. Clinically, patients in this group exhibit greater susceptibility to infections and cardiovascular events, along with an elevated risk of disease progression, resulting in a significantly reduced overall survival. Functional studies demonstrate that PU.1 inhibition suppresses MDS cell proliferation and clonogenicity, as impaired PU.1 binding inhibits the activation of key transcriptional programs involved in disease advancement. Collectively, these findings identify epigenetic factors that predispose low-risk MDS patients to progression into high-risk MDS and, ultimately, sAML.

骨髓增生异常综合征（MDS）是一种异质性髓系肿瘤，其进展为继发性急性髓系白血病（sAML）的风险增加。本研究通过H3K27ac ChIP-seq和RNA-seq分析分别从86例和357例患者中分离的CD34+骨髓祖细胞，分析活跃的基因组调控区域及其转录影响，研究MDS疾病进展的基因组相关因素。我们的分析揭示了不同疾病阶段（低风险MDS、高风险MDS和sAML）基因组区域激活和转录调控的不同模式。出乎意料的是，无监督聚类揭示了低风险MDS患者的一个子集显示出与高风险MDS和sAML相似的调控和转录谱，突出了可能使患者易患疾病进展的早期分子事件。该亚群的特征是PU.1基因组占据与免疫和炎症反应相关的区域，增加t细胞和NK激活，以及更高频率的SRSF2突变。在临床上，该组患者对感染和心血管事件表现出更大的易感性，同时疾病进展风险升高，导致总生存期显着降低。功能研究表明，抑制PU.1抑制MDS细胞增殖和克隆原性，因为受损的PU.1结合抑制了参与疾病进展的关键转录程序的激活。总的来说，这些发现确定了易使低风险MDS患者进展为高风险MDS并最终发展为sAML的表观遗传因素。

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引用次数: 0

Prior transplantation and idecabtagene vicleucel in multiple myeloma: a secondary analysis of CIBMTR data. 多发性骨髓瘤的既往移植和idecabtagene微核：CIBMTR数据的二次分析。

IF 23.1 1区医学 Q1 HEMATOLOGY

Blood

Pub Date : 2026-01-15 DOI: 10.1182/blood.2025031426

Rahul Banerjee, Christy Khouderchah, Othman S Akhtar, Emily C Liang, Jordan Gauthier, Madhav V Dhodapkar, Andrew J Portuguese

Abstract: Recent analyses have suggested a possible negative impact of prior autologous stem cell transplantation on outcomes with idecabtagene vicleucel (ide-cel) chimeric antigen receptor T-cell therapy in relapsed/refractory multiple myeloma. Our registry-based analysis of >800 ide-cel recipients did not identify any such association.

N/A。

引用次数: 0

Elevated serum erythropoietin level in JAK2+ polycythemia vera with small vessel Budd-Chiari syndrome. JAK2+真性红细胞增多症合并小血管Budd-Chiari综合征血清促红细胞生成素水平升高。

IF 20.3 1区医学 Q1 HEMATOLOGY

Blood

Pub Date : 2026-01-15 DOI: 10.1182/blood.2025031930

Yaswanta K Gummadi,Amy M Trottier

引用次数: 0

Resistance is not futile: RAS inhibition resensitizes AML. 抗药并非徒劳：RAS抑制可使AML重致敏。

IF 20.3 1区医学 Q1 HEMATOLOGY

Blood

Pub Date : 2026-01-15 DOI: 10.1182/blood.2025031932

Cailin Collins,Ravindra Majeti

引用次数: 0

Multinational assessment of absolute neutrophil counts and white blood cell counts among healthy Duffy-null adults. 健康Duffy Null成人绝对中性粒细胞计数和白细胞计数的多国评估。

IF 23.1 1区医学 Q1 HEMATOLOGY

Blood

Pub Date : 2026-01-15 DOI: 10.1182/blood.2025029359

Stephen P Hibbs, Israel Chipare, Amr J Halawani, Sophie E Legge, Geoffrey Fell, Daniel Dees, David J Roberts, Nicholas Gleadall, Olga Shamardina, Abdulrahman A Alhamzi, Edwig Shingenge, Mohammed J Alabdly, Hilary T Charuma, Mohammed A Nushaily, Judith M Sinvula, Menelik Russo, Michelle Sholzberg, Sara Paparini, Vanessa Apea, Maureen Okam Achebe, Nancy Berliner, Lauren E Merz

Abstract: Laboratory reference intervals must reflect population diversity for accurate medical decisions. The Duffy-null variant lowers absolute neutrophil counts (ANC), but existing dedicated reference intervals are based on a single African American cohort. The impact across other ethnic groups and regions remains unclear, and no white blood cell count (WBC) intervals exist for Duffy-null individuals. This study aimed to establish and compare Duffy-null ANC and WBC reference intervals across 4 continents. A cross-sectional study was conducted assessing healthy Duffy-null individuals from dedicated cohorts (blood donors in Namibia, Saudi Arabia, and the United Kingdom; primary care patients in the United States) and biobanks (participants from the United Kingdom and the United States). Among 8018 participants (880 from dedicated cohorts and 7138 from biobanks), novel ANC and WBC reference intervals were established (Namibia [ANC, 820/μL to 6370/μL; WBC, 2.51 × 109/L to 9.85 × 109/L]; Saudi Arabia [ANC, 1140/μL to 5290/μL; WBC, 3.72 × 109/L to 10.71 × 109/L]; United Kingdom (ANC, 1185/μL to 5462/μL; WBC, 3.1 × 109/L to 8.8 × 109/L]; the United States [ANC, 1210/μL to 5390/μL; WBC, 3.00 × 109/L to 9.66 × 109/L]), with no significant differences between cohorts. Institutional reference intervals misclassified 27.9% (Namibia), 50.9% (Saudi Arabia), 26.0% (United Kingdom), and 21.7% (the United States) as neutropenic. Biobank analyses confirmed no significant difference in ANC between Black and non-Black Duffy-null participants. Duffy-null individuals consistently exhibit lower ANC and WBC across ethnic groups and regions. Current reference intervals overlook this variation, risking misdiagnosis and health inequities. Implementing Duffy-specific reference intervals is essential for equitable and accurate clinical decisions worldwide.

为了做出准确的医疗决定，实验室参考区间必须反映人群的多样性。Duffy null变异降低绝对中性粒细胞计数（ANC），但现有的专用参考区间是基于单一的非裔美国人队列。对其他种族和地区的影响尚不清楚，Duffy null个体不存在白细胞计数（WBC）间隔。本研究旨在建立和比较四大洲的Duffy零ANC和WBC参考区间。进行了一项横断面研究，评估了来自专门队列（纳米比亚、沙特阿拉伯和英国的献血者；美国的初级保健患者）和生物库（来自英国和美国的参与者）的健康Duffy null个体。参考区间根据临床与实验室标准协会指南确定。在8,018名参与者中（880名来自专门队列，7,138名来自生物库），建立了新的ANC和WBC参考区间：纳米比亚（820-6,370/ μ L; 2.51-9.85× 109/L），沙特阿拉伯（1,140-5,290/ μ L; 3.72-10.71× 109/L），英国（1,185-5,462/ μ L; 3.1-8.8× 109/L）和美国（1,210-5,390/ μ L; 3.00-9.66× 109/L），队列之间无显著差异。机构参考区间错误地将27.9%（纳米比亚）、50.9%（沙特阿拉伯）、26.0%（英国）和21.7%（美国）分类为中性粒细胞减少。生物银行分析证实黑人和非黑人Duffy无效参与者之间的ANC无显著差异。Duffy null个体在不同种族和地区均表现出较低的ANC和WBC。目前的参考区间忽略了这种差异，有误诊和卫生不公平的风险。实施达菲特异性参考区间对于全球公平和准确的临床决策至关重要。

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引用次数: 0

Duffy-null reference ranges for improved clinical care. 改善临床护理的Duffy-null参考范围。

IF 20.3 1区医学 Q1 HEMATOLOGY

Blood

Pub Date : 2026-01-15 DOI: 10.1182/blood.2025032115

Laura M Raffield,Alexander P Reiner

引用次数: 0

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