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助周期实施的试验。这将结合联合收割机建立核心中心在前2个资助周期与一个证明的跟踪记录，一贯满足或超过所有年度BMTCTN的性能标准，超过目标招生目标在过去2年，并在各种BMTCTN委员会和协议中提供领导，并设有附属中心（欧盟）它是BMTCTN的一个大型附属中心，在BMTCTN试验中有大量患者招募的记录，并承诺扩大招募。该联盟的优势在于，该核心将能够使BMTCTN试验的应计费用增加一倍以上。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的最佳预处理方案，在自体造血干细胞移植（HSCT）前测试高剂量美法仑+硼替佐米与单独美法仑的组合作为预处理。该拟议方案解决了2007年BMT CTN科学研讨会中确定的六个高优先级研究问题之一（复发），并从核心联盟内部的试点试验中产生。相关性（参见说明）：该项目解决了很少有造血细胞移植（HCT）患者，特别是异基因HCT患者进入临床试验以探索改善结局的策略的问题。拟议的方案解决了这样一个事实，即HSCT治疗多发性骨髓瘤可提高缓解率和生存率，但很少因复发而治愈。更好的调理方案为改善反应和治愈提供了希望。

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.