Core Clinical Consortium for Blood and Marrow Transplant Clinical Trials Network

描述（由申请人提供）：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，用于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助周期实施的试验。这将结合一个在前两个资金周期内建立的核心中心，以及一个持续达到或超过所有年度BMTCTN绩效标准的可靠记录，超过过去两年的目标招生目标，并与BMTCTN附属中心（EU）一起领导各种BMTCTN委员会和协议，该附属中心一直是BMTCTN的大型附属中心，具有BMTCTN试验中大量患者登记的记录，并致力于扩大登记。该联盟的优势在于，这一核心将能够使BMTCTN试验的累积收益增加一倍以上。该项目还将提出一项前瞻性III期临床试验，以评估骨髓瘤患者首次HSCT的最佳调节方案，测试大剂量美法兰加硼替佐米的组合与单独美法兰作为自体造血干细胞移植（HSCT）前的调节。该提议方案解决了2007年BMT CTN科学状况研讨会确定的六个高优先级研究问题之一（复发），并源于核心联盟内部的一项试点试验。相关性（见说明）：本项目关注的是，很少有造血细胞移植（HCT）患者，特别是异体造血细胞移植患者进入临床试验，以探索改善预后的策略。提议的方案解决了这样一个事实，即多发性骨髓瘤的HSCT提高了反应率和生存率，但由于复发很少导致治愈。更好的调理方案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.