CLINICAL RESEARCH PROJECT 
Date 
Project # Mdlzl 17 
Drug/Device # 
IND/IDE # 
IND/IDE Holder: 
Burroughs-Wellcome 
To: Joel Moss, M.D./ Acting Chair, ICRS, NHLBI 
Recommended by: 
Harry Kelser, M..D. , Clinical Director, NHLBI 
Title : High-Dose Melphalan and Total Body Irradiation with 
Autologous Bone Marrow and Peripheral Blood Stem Cell 
Support Followed by Interferon for Multiple Myeloma 
Other Identifying Words : granulocyte colony 
stimulating factor, cyclophosphamide, 5-f luorouracil, 
bone marrow transplantation, stem cell, 
apheresis, peripheral blood stem cell 
Principle Investigator : 
Cynthia E. Dunbar, M.D., Senior Clinical Investigator, 
CHB, NHLBI A£}> 
Medically Responsible Investigator : 
Cynthia E. Dunbar, M.D., Senior Clinical Investigator, 
CHB, NHLBI f 
Associate Investigators : 
r Arthur W. Nienhuis, M.D., Chief, CHB, NHLBI 
F. Marc Stewart, M.D., University of^Virginia School of 
Medicine, Charlottesville, VA r 
Neal'S. Young, M.D., Section Chief, CHB, NHLBI 
Michele Cottier-Fox, M.D., Department of Transfusion 
Medicine, Clinical Center jH 
Frank Sullivan, M.D., Radiation Oncology Branch, NCIjo 
Susan Leitman, M.D., Department of Transfusion 
Medicine, Clinical Centeir^j^r^ 
Estimated .Duration of Study: 3 years 
Subjects of Study: 
Patients 
Number 
2-4 .. 
Sex 
either 
Age Range 
18-65 
Project uses ionizing radiation? Yes 
Radiation use is medically indicated 
Project involves use of Durable Power of Attorney? No 
Off-site project? No ‘ u , 
Multi-Institutional Project? Yes 
Collaborating Institute Clinical Director 
Recombinant DNA Research, Volume 16 
Dr. Gregory Curt/ Clinical Director, NCI 
[31] 
