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.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HL069301-15
Application #
8860224
Study Section
Special Emphasis Panel (ZHL1)
Program Officer
Di Fronzo, Nancy L
Project Start
2001-09-30
Project End
2016-06-30
Budget Start
2015-07-01
Budget End
2016-06-30
Support Year
15
Fiscal Year
2015
Total Cost
Indirect Cost
Name
University of Florida
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
969663814
City
Gainesville
State
FL
Country
United States
Zip Code
32611
Wood, William A; Le-Rademacher, Jennifer; Syrjala, Karen L et al. (2016) Patient-reported physical functioning predicts the success of hematopoietic cell transplantation (BMT CTN 0902). Cancer 122:91-8
Young, Jo-Anne H; Logan, Brent R; Wu, Juan et al. (2016) Infections after Transplantation of Bone Marrow or Peripheral Blood Stem Cells from Unrelated Donors. Biol Blood Marrow Transplant 22:359-370
Steering Committee Of The Blood And Marrow Transplant Clinical Trials Network (2016) The Blood and Marrow Transplant Clinical Trials Network: An Effective Infrastructure for Addressing Important Issues in Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant 22:1747-1757
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
Khera, Nandita; Majhail, Navneet S; Brazauskas, Ruta et al. (2015) Comparison of Characteristics and Outcomes of Trial Participants and Nonparticipants: Example of Blood and Marrow Transplant Clinical Trials Network 0201 Trial. Biol Blood Marrow Transplant 21:1815-22
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
Cutler, Corey; Logan, Brent; Nakamura, Ryotaro et al. (2014) Tacrolimus/sirolimus vs tacrolimus/methotrexate as GVHD prophylaxis after matched, related donor allogeneic HCT. Blood 124:1372-7
Eapen, Mary; O'Donnell, Paul; Brunstein, Claudio G et al. (2014) Mismatched related and unrelated donors for allogeneic hematopoietic cell transplantation for adults with hematologic malignancies. Biol Blood Marrow Transplant 20:1485-92
Roth, Joshua A; Bensink, Mark E; O'Donnell, Paul V et al. (2014) Design of a cost-effectiveness analysis alongside a randomized trial of transplantation using umbilical cord blood versus HLA-haploidentical related bone marrow in advanced hematologic cancer. J Comp Eff Res 3:135-44

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