AMENDMENT TO CLINICAL RESEARCH PROJECTS 
Project #s : 92-H-56 .92-H-57 
IND/IDE # 
IND/IDE Holder: 
Date 
To: Joel Moss, M.D. , Acting Chair, ICRS, NHLBI 
Recommended by: 
Harry Reiser, M.D., Clinical Director, NHLBI 
Amendment Title : Genetic Marking With Retroviral Vectors to 
Study the Feasibility of Stem Cell Gene Transfer and the 
Biology of Hematopoietic Reconstitution After Autologous 
Transplantation in Multiple Myeloma, Chronic Myelogenous 
Leukemia, or Metastatic Breast Cancer 
Protocol Titles : 92-H-56 : High-Dose Cyclophosphamide and Total 
Body Irradiation with Autologous Bone Marrow and Peripheral 
Blood Stem Cell Support Followed by Interferon for Treatment 
of Chronic Myelogenous Leukemia 
92— H— 57 : High-Dose Melphalan and Total Body Irradiation with 
Autologous Bone Marrow and Peripheral Blood Stem Cell 
Support Followed by Interferon for Multiple Myeloma 
£JCI: Pilot Study of High-Dose ICE ( If osf amide, Carboplatin, 
Etoposide) Chemotherapy and Autologous Bone Marrow 
Transplant ( ABMT) with Neo -Transduced Bone Marrow Stem Cells 
Other Identifying Words : retroviral gene transfer, gene therapy, 
autologous stem cell transplantation, CD34 positive 
selection 
Principle Investigator : 
Cynthia,E. Dunbar, M.D. , Senior Clinical Investigator, CHB , 
NHLBI L> 
Medically Responsible Investigator : 
Cynthia E. Dunbar, M.D., Senior Clinical Investigator, CHB, 
NHLBI CfC . £> ' 
Associate Investigators :' 
Arthur W. Nienhuis, M.D., Chief, CHB, NHLBI 
F. Marc Stewart, M.D., University ofVirginia Schbol of 
Medicine, Charlottesville, VA 
Joyce O'Shaughnessy , 
Kenneth Cowan, M.D., 
Michele Cottier-Fox, 
Susan Leitman, M.D., 
Stacey Goodman , M.D. 
Brian P. Sorrentino, 
Kevin McDonagh, M.D. 
iter 
M.D., MB, NCI^K 
Ph . D . , MB, NCI fC 
M.D., DTM, Clinical 
DTM, Clinical^CenteL^^ — 
CHB, NHLB 
M.D., NHLBI# 5 ^ 
NHLBI 0 i 
Section Chief, CHB, NHLBI 
Neal S. Young, M.D., 
Robert Donahue, D.V.M. , CHB, NHLBI ^0 
David Bodine, PhD., CHB, NHLBl£)iM^) 
Aliza Cassell, PhD., CHB, NHLBI 
Wyndham Wilson, M.D., MB, NCI ']/jW V 
[ 2 ] 
Recombinant DNA Research, Volume 16 
