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.

Public Health Relevance

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.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Special Emphasis Panel (ZHL1-CSR-K (M3))
Program Officer
Di Fronzo, Nancy L
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University of Florida
Internal Medicine/Medicine
Schools of Medicine
United States
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Holstein, Sarah A; Jung, Sin-Ho; Richardson, Paul G et al. (2017) Updated analysis of CALGB (Alliance) 100104 assessing lenalidomide versus placebo maintenance after single autologous stem-cell transplantation for multiple myeloma: a randomised, double-blind, phase 3 trial. Lancet Haematol 4:e431-e442
Wingard, John R; Wood, William A; Martens, Michael et al. (2017) Pretransplantation Exercise and Hematopoietic Cell Transplantation Survival: A Secondary Analysis of Blood and Marrow Transplant Clinical Trials Network (BMT CTN 0902). Biol Blood Marrow Transplant 23:161-164
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Appelbaum, Frederick R; Anasetti, Claudio; Antin, Joseph H et al. (2015) Blood and marrow transplant clinical trials network state of the Science Symposium 2014. Biol Blood Marrow Transplant 21:202-24
Zhang, J; Mosunjac, M; Moon, A et al. (2015) Tuberculosis in umbilical cord blood transplant recipients: clinical characteristics and challenges. Bone Marrow Transplant 50:465-8
Yanik, Gregory A; Horowitz, Mary M; Weisdorf, Daniel J et al. (2014) Randomized, double-blind, placebo-controlled trial of soluble tumor necrosis factor receptor: enbrel (etanercept) for the treatment of idiopathic pneumonia syndrome after allogeneic stem cell transplantation: blood and marrow transplant clinical trials ne Biol Blood Marrow Transplant 20:858-64
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