Core Clinical Consortium for Blood and Marrow Transplant Clinical Trials Network

描述(由申请者提供)：该项目将建立一个由佛罗里达大学(UF)和埃默里大学(EU)组成的核心临床联盟，以执行血液和骨髓移植临床试验网络(BMTCTN)的试验，并参与多项正在进行的试验和将在下一个资金周期实施的试验。这将把在前两个资助周期建立的核心中心与一贯达到或超过所有BMTCTN年度绩效标准、超过过去两年的目标登记目标的可靠记录结合在一起，并在BMTCTN的各种委员会和方案中提供领导，附属中心(EU)一直是BMTCTN的大型附属中心，在BMTCTN试验中有大量患者登记的记录，并承诺扩大登记。该联盟的优势是，这一核心将能够将其在BMTCTN试验中的收益增加一倍以上。该项目还将提出一项前瞻性的III期临床试验，以评估首次骨髓瘤患者HSCT的最佳调理方案，测试在自体造血干细胞移植(HSCT)之前，大剂量马法兰联合Bortezomib和马法兰单独作为调理方案。这项拟议的议定书解决了2007年BMT CTN科学状况研讨会确定的六个高优先级研究问题(复发)之一，并源于核心联合体内的一项试点试验。相关性(见说明)：该项目解决了很少有造血细胞移植(HCT)患者，特别是异基因造血细胞移植患者进入临床试验以探索改善结果的策略的问题。建议的方案解决了这样一个事实，即HSCT治疗多发性骨髓瘤提高了应答率和存活率，但由于复发而很少治愈。更好的调理疗法提供了改善反应和治愈的希望。

DESCRIPTION (provided by applicant): The project will establish a core clinical consortium consisting of the University of Florida (UF) and Emory University (EU) for the performance of trials of the Blood and Marrow Transplant Clinical Trials Network (BMTCTN) with participation in multiple ongoing trials and trials to be implemented in the next funding cycle. This will combine an established core center during the first 2 funding cycles with a proven track record of consistently meeting or exceeding all annual BMTCTN performance standards, exceeding target enrollment goals during the past 2 years, and providing leadership in a variety of BMTCTN committees and protocols with an affiliate center (EU) that has been a large affiliate center of the BMTCTN with a track record of substantial patient enrollment in BMTCTN trials and a commitment to expand enrollment. The advantage of the consortium is that together this core will be able to more than double its accrual to BMTCTN trials. The project will also propose a prospective phase III clinical trial to evaluate the optimal conditioning regimen for the first HSCT of myeloma patients testing the combination of high-dose melphalan plus bortezomib versus melphalan alone as conditioning prior to autologous hematopoietic stem cell transplantation (HSCT). This proposed protocol addresses one of the six high-priority research questions (relapse) identified in the 2007 BMT CTN State of Science Symposium and grew out of a pilot trial that originated from within the core consortium. RELEVANCE (See instructions): This project addresses the concern that few hematopoietic cell transplant (HCT) patients, especially allogeneic HCT patients, enter clinical trials to explore strategies to improve outcomes. The proposed protocol addresses the fact that HSCT for multiple myeloma improves response rates and survival but rarely results in cure due to relapse. Better conditioning regimens offer the hope to improve responses and cure.