统一临床试验报告的共识建议：国际骨髓瘤工作组共识小组报告 1.
Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1.
机构信息
Mayo Clinic, Rochester, MN, USA.
出版信息
Blood. 2011 May 5;117(18):4691-5. doi: 10.1182/blood-2010-10-299487. Epub 2011 Feb 3.
Abstract
It is essential that there be consistency in the conduct, analysis, and reporting of clinical trial results in myeloma. The goal of the International Myeloma Workshop Consensus Panel 1 was to develop a set of guidelines for the uniform reporting of clinical trial results in myeloma. This paper provides a summary of the current response criteria in myeloma, detailed definitions for patient populations, lines of therapy, and specific endpoints. We propose that future clinical trials in myeloma follow the guidelines for reporting results proposed in this manuscript.
摘要
在骨髓瘤的临床试验结果的实施、分析和报告中保持一致性至关重要。国际骨髓瘤工作组共识小组的目标是制定一套用于统一报告骨髓瘤临床试验结果的指南。本文总结了目前骨髓瘤的缓解标准，详细定义了患者人群、治疗线和具体终点。我们建议未来的骨髓瘤临床试验遵循本文提出的报告结果指南。
相似文献
1
Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1.统一临床试验报告的共识建议：国际骨髓瘤工作组共识小组报告 1.
Blood. 2011 May 5;117(18):4691-5. doi: 10.1182/blood-2010-10-299487. Epub 2011 Feb 3.
2
Consensus recommendations for risk stratification in multiple myeloma: report of the International Myeloma Workshop Consensus Panel 2.多发性骨髓瘤风险分层的共识建议：国际骨髓瘤工作组共识小组报告 2.
Blood. 2011 May 5;117(18):4696-700. doi: 10.1182/blood-2010-10-300970. Epub 2011 Feb 3.
3
Consensus recommendations for standard investigative workup: report of the International Myeloma Workshop Consensus Panel 3.共识建议的标准调查研究：国际骨髓瘤工作组共识小组 3 的报告。
Blood. 2011 May 5;117(18):4701-5. doi: 10.1182/blood-2010-10-299529. Epub 2011 Feb 3.
4
BMT CTN Myeloma Intergroup Workshop on Minimal Residual Disease and Immune Profiling: Summary and Recommendations from the Organizing Committee.BMT CTN 骨髓瘤协作组微小残留病和免疫特征分析工作组会议：会议组织委员会总结与建议
Biol Blood Marrow Transplant. 2018 Apr;24(4):641-648. doi: 10.1016/j.bbmt.2017.12.774. Epub 2017 Dec 11.
5
Clinically relevant end points and new drug approvals for myeloma.骨髓瘤的临床相关终点和新药批准
Leukemia. 2008 Feb;22(2):231-9. doi: 10.1038/sj.leu.2405016. Epub 2007 Nov 1.
6
The future of Cochrane Neonatal.考克兰新生儿协作网的未来。
Early Hum Dev. 2020 Nov;150:105191. doi: 10.1016/j.earlhumdev.2020.105191. Epub 2020 Sep 12.
7
Recent advances in the management of multiple myeloma: clinical impact based on resource-stratification. Consensus statement of the Asian Myeloma Network at the 16th international myeloma workshop.多发性骨髓瘤管理的最新进展：基于资源分层的临床影响。亚洲骨髓瘤网络在第16届国际骨髓瘤研讨会的共识声明。
Leuk Lymphoma. 2018 Oct;59(10):2305-2317. doi: 10.1080/10428194.2018.1427858. Epub 2018 Feb 2.
8
Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke.急性缺血性脑卒中动脉内脑溶栓的试验设计与报告标准。
Stroke. 2003 Aug;34(8):e109-37. doi: 10.1161/01.STR.0000082721.62796.09. Epub 2003 Jul 17.
9
Standardizing definitions and reporting guidelines for the infertility core outcome set: an international consensus development study.制定不孕不育核心结局集的定义和报告指南：国际共识发展研究。
Fertil Steril. 2021 Jan;115(1):201-212. doi: 10.1016/j.fertnstert.2020.11.013. Epub 2020 Nov 30.
10
Proceedings from the Blood and Marrow Transplant Clinical Trials Network Myeloma Intergroup Workshop on Immune and Cellular Therapy in Multiple Myeloma.来自血液和骨髓移植临床研究网络骨髓瘤协作组关于多发性骨髓瘤免疫和细胞治疗的研讨会会议记录。
Transplant Cell Ther. 2022 Aug;28(8):446-454. doi: 10.1016/j.jtct.2022.05.019. Epub 2022 May 21.
引用本文的文献
1
Role of Composite Measurable Residual Disease Assessment with PET-CT and flow cytometry in Multiple Myeloma patients undergoing Autologous Transplant.PET-CT和流式细胞术联合检测可测量残留病评估在接受自体移植的多发性骨髓瘤患者中的作用
Blood Cell Ther. 2025 Jul 25;8(3):234-243. doi: 10.31547/bct-2025-002. eCollection 2025 Aug 25.
2
Ibrutinib in Combination with Lenalidomide Revlimid/Dexamethasone in Relapsed/Refractory Multiple Myeloma (AFT-15).依鲁替尼联合来那度胺/地塞米松治疗复发/难治性多发性骨髓瘤（AFT-15）
Cancers (Basel). 2025 Jul 23;17(15):2433. doi: 10.3390/cancers17152433.
3
Consensus Guidelines and Recommendations for the anti-CD38-based Therapy in Clinical Practice for Relapsed/Refractory Multiple Myeloma: From the Pan-Pacific Multiple Myeloma Working Group.《复发/难治性多发性骨髓瘤临床实践中基于抗CD38治疗的共识指南与建议：来自泛太平洋多发性骨髓瘤工作组》
Clin Hematol Int. 2025 Aug 8;7(3):36-59. doi: 10.46989/001c.141401. eCollection 2025.
4
Comparative Effectiveness of Ciltacabtagene Autoleucel in CARTITUDE-4 Versus Real-World Physician's Choice of Therapy from the Flatiron Registry in Lenalidomide-Refractory Multiple Myeloma.cilta-cabtagene autoleucel在CARTITUDE-4研究中与来那度胺难治性多发性骨髓瘤患者实际接受的医生选择治疗方案相比的疗效对比：来自Flatiron注册研究的数据
Adv Ther. 2025 Aug 6. doi: 10.1007/s12325-025-03308-2.
5
Talquetamab improves patient-reported symptoms and health-related quality of life in relapsed or refractory multiple myeloma: Results from the phase 1/2 MonumenTAL-1 study.塔奎塔单抗可改善复发或难治性多发性骨髓瘤患者报告的症状及与健康相关的生活质量：1/2期MonumenTAL-1研究结果
Cancer. 2025 Jul 15;131(14):e35927. doi: 10.1002/cncr.35927.
6
Phase 1b study of the anti-CD38 antibody mezagitamab in patients with relapsed/refractory multiple myeloma.抗CD38抗体美扎吉他单抗用于复发/难治性多发性骨髓瘤患者的1b期研究。
Blood Neoplasia. 2024 Sep 18;1(4):100043. doi: 10.1016/j.bneo.2024.100043. eCollection 2024 Dec.
7
Successful treatment of smoldering multiple myeloma-associated type I cryoglobulinemia with bortezomib and autologous peripheral blood stem cell transplantation.硼替佐米与自体外周血干细胞移植成功治疗冒烟型多发性骨髓瘤相关的I型冷球蛋白血症。
J Clin Exp Hematop. 2025 Jun 28;65(2):121-128. doi: 10.3960/jslrt.25001. Epub 2025 May 30.
8
Sequential Myelomatous Pleural and Pericardial Effusions in Multiple Myeloma: A Case Report Demonstrating Extended Survival with Teclistamab.多发性骨髓瘤患者的序贯性骨髓瘤性胸腔和心包积液：一例使用替雷利珠单抗实现长期生存的病例报告
Case Rep Oncol. 2025 May 26;18(1):620-629. doi: 10.1159/000545930. eCollection 2025 Jan-Dec.
9
Attrition rates and treatment outcomes in multiple myeloma: real-world data over a 40-year period.多发性骨髓瘤的损耗率和治疗结果：40年期间的真实世界数据。
Blood Cancer J. 2025 May 26;15(1):103. doi: 10.1038/s41408-025-01311-y.
10
Analysis of pharmacotherapeutic approaches for multiple myeloma and correlated renal and pulmonary impairments: a retrospective real-world registry study in the Greater Gulf Region (REPAIR Study).多发性骨髓瘤及相关肾肺损伤的药物治疗方法分析：大湾地区的一项回顾性真实世界注册研究（REPAIR研究）
Front Oncol. 2025 May 9;15:1547138. doi: 10.3389/fonc.2025.1547138. eCollection 2025.
本文引用的文献
1
The importance of bone marrow examination in determining complete response to therapy in patients with multiple myeloma.骨髓检查在确定多发性骨髓瘤患者对治疗的完全缓解中的重要性。
Blood. 2009 Sep 24;114(13):2617-8. doi: 10.1182/blood-2009-01-198788. Epub 2009 Jul 29.
2
Criteria for diagnosis, staging, risk stratification and response assessment of multiple myeloma.多发性骨髓瘤的诊断、分期、风险分层及疗效评估标准。
Leukemia. 2009 Jan;23(1):3-9. doi: 10.1038/leu.2008.291. Epub 2008 Oct 30.
3
Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma.硼替佐米联合美法仑和泼尼松用于多发性骨髓瘤的初始治疗。
N Engl J Med. 2008 Aug 28;359(9):906-17. doi: 10.1056/NEJMoa0801479.
4
The relationship between quality of response and clinical benefit for patients treated on the bortezomib arm of the international, randomized, phase 3 APEX trial in relapsed multiple myeloma.在国际随机3期APEX试验的硼替佐米治疗组中，复发多发性骨髓瘤患者的缓解质量与临床获益之间的关系。
Br J Haematol. 2008 Oct;143(1):46-53. doi: 10.1111/j.1365-2141.2008.07303.x. Epub 2008 Jul 31.
5
Eliminating the complete response penalty from myeloma response criteria.从骨髓瘤缓解标准中消除完全缓解惩罚。
Blood. 2008 Jun 15;111(12):5759-60. doi: 10.1182/blood-2008-04-151118.
6
Eliminating the complete response penalty from myeloma response assessment.在骨髓瘤反应评估中消除完全缓解惩罚。
Blood. 2008 Mar 15;111(6):3297-8. doi: 10.1182/blood-2008-01-132456.
7
Multiple myeloma.多发性骨髓瘤
Blood. 2008 Mar 15;111(6):2962-72. doi: 10.1182/blood-2007-10-078022.
8
Clinically relevant end points and new drug approvals for myeloma.骨髓瘤的临床相关终点和新药批准
Leukemia. 2008 Feb;22(2):231-9. doi: 10.1038/sj.leu.2405016. Epub 2007 Nov 1.
9
Assessing response rates in clinical trials of treatment for relapsed or refractory multiple myeloma: a study of bortezomib and thalidomide.评估复发或难治性多发性骨髓瘤治疗临床试验中的缓解率：硼替佐米与沙利度胺的研究
Leukemia. 2007 Apr;21(4):818-20; author reply 821. doi: 10.1038/sj.leu.2404573. Epub 2007 Feb 15.
10
International uniform response criteria for multiple myeloma.多发性骨髓瘤的国际统一反应标准。
Leukemia. 2006 Sep;20(9):1467-73. doi: 10.1038/sj.leu.2404284. Epub 2006 Jul 20.
Zotero 插件