MEDICAL RECORD 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
• Adult Patient or • Parent, for Minor Patient 
iw^TiTliTF- National Heart/ Lung and Blood Institute 
JDY NUMBER 
PRINCIPAL INVESTIGATOR: Cynthia E. Dunbar, M.D. 
STUDY TITLE: High-Dose Melphalan and Total Body Irradiation with Autoloaous Bone Marrow 
and Peripheral Blood Stem Cell Support Followed by Interferon for Multiple Myeloma. 
— 
INTRODUCTION 
We Invite you (or your child) to take part in a research study at the National Institutes of Health. It is important that you 
read and understand several general principles that apply to all who take part in our studies: (a) taking part in the study 
is entirely voluntary; (b) personal benefit may not result from taking part in the study, but knowledge may be gained that 
will benefit others; (c) you may withdraw from the study at any time without penalty or loss of any benefits to which you 
are otherwise entitled. The nature of the study, the risks, inconveniences, discomforts, and other pertinent information 
about the study are discussed below. You are urged to discuss any questions you have about this study with the staff 
members whp explain it to you. 
We invite you to participate in a study of very 
aggressive high-dose therapies to treat multiple myeloma. You 
were selected for this study because you are under the age of 
65 and have chemotherapy-responsive multiple myeloma. These 
treatments are experimental and we do not know if your life 
will be prolonged by them or if you will be cured of your 
multiple myeloma. The . purpose of this study is to determine 
the safety and effectiveness of this type of treatment. -This 
consent form will describe why we think this type of treatment 
might help you, what this treatment involves and what it's 
risks are, and what alternative treatments exist. 
You have a serious disease called multiple myeloma, a 
cancer of bone marrow cells called plasma cells. When these 
cells grow in large numbers in the bone, they can cause pain 
and fractures. They can also crowd out normal bone marrow 
cells, and thus decrease the ability to make red blood cells, 
white blood cells, and platelets. As a result, myeloma 
patients can become anemic, develop abnormal bleeding, and 
have trouble with serious infections. These abnormal plasma 
cells can secrete large amounts of proteins called antibodies 
that may cause kidney or brain damage. Chemotherapy medicines 
can often decrease the number of these abnormal cells, and and 
relieve some of the symptoms of the disease. Radiation 
treatments can prevent* * plasma cell tumors from further 
damaging the bones, and decrease bony pain. You have already 
received these types of treatments, and your tumor has been 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
RESEARCH STUDY 
• Adult Patient or • Parent, for Minor Patient 
[70] 
Recombinant DNA Research, Volume 16 
