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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.

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.

DOI:10.1182/blood-2010-10-299487
PMID:21292775
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3710442/
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。