Core Clinical Consortium for Blood and Marrow Transplant Clinical Trials Network

血液和骨髓移植临床试验网络核心临床联盟

• 批准号: 8316292
• 负责人: JOHN R. WINGARD
• 金额: $ 14.63万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-30 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8316292
• 关键词: Address; Allogenic; Autologous; Blood; Bortezomib; Cell Transplants; Clinical; Clinical Trials; Clinical Trials Network; Dose; Enrollment; Florida; Funding; Goals; Hematopoietic; Hematopoietic Stem Cell Transplantation; Instruction; Leadership; Marrow; Melphalan; Multiple Myeloma; Outcome; Patients; Performance; Phase III Clinical Trials; Progression-Free Survivals; Protocols documentation; Regimen; Relapse; Research Priority; Science; Survival Rate; Testing; Transplant Recipients; Transplantation; United States National Institutes of Health; Universities; conditioning; improved; meetings; novel; pilot trial; prospective; response; symposium

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.

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，负责血液和骨髓移植临床试验网络（BMTCTN）的试验，参与多项正在进行的试验以及将在下一个资助周期实施的试验。这将把在前 2 个资助周期内建立的核心中心与一贯满足或超过所有年度 BMTCTN 绩效标准、在过去 2 年内超过目标入组目标、并在各种 BMTCTN 委员会和协议中提供领导作用的良好记录与附属中心 (EU) 结合起来，该附属中心是 BMTCTN 的大型附属中心，在 BMTCTN 试验中拥有大量患者入组记录 并承诺扩大招生规模。该联盟的优势在于，该核心将能够将 BMTCTN 试验的应计额增加一倍以上。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，测试大剂量美法仑加硼替佐米的组合与单独使用美法仑作为自体造血干细胞移植 (HSCT) 前的预处理。该拟议方案解决了 2007 年 BMT CTN 科学状况研讨会上确定的六个高度优先研究问题（复发）之一，并源自核心联盟内部的一项试点试验。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（尤其是同种异体 HCT 患者）进入临床试验以探索改善结果的策略的担忧。拟议的方案解决了多发性骨髓瘤的 HSCT 可以提高缓解率和生存率，但由于复发而很少导致治愈的事实。更好的调理方案为改善反应和治愈带来了希望。