MEDICAL 
RECORD 
CONTINUATION SHEET for either: 
NIH 25 14-1, Consent to Participate in A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate in A Clinical 
Research Study 
STUDY NUMBER: 
CONTINUATION: page _A_ of __6_ page: 
Should you die, for any cause, we will request that an autopsy be performed to study whether the 
neor" gene is present in your body. 
If your myeloma relapses or is found in a new part of your body after bone marrow 
transplant, a bone marrow aspiration and biopsy will be obtained under local anesthesia to look 
D 
for the presence of the neo^ gene in the tumor cells as well as to assess the extent of your 
disease. 
RISKS AND TOXICITIES 
R 
No side effects from the neo^ marker genes and the transporter viruses to be used in this 
study have been seen in animal studies or in the very limited human studies on gene transfer 
which began in May, 1989. However, since this is a very new procedure, the risks may not be 
known. There are some theoretical risks to this procedure. First, even though the viruses used to 
insert the gene into your bone marrow and blood cells cannot grow and are considered harmless, 
it is possible that events could occur within the cells that allow the viruses to grow or cause the 
cell to become cancerous. It is also theoretically possible that you could become infected with 
the virus. Since this has never happened, the consequences of such an infection are unknown. 
Also, the inserted gene produces a substance that inactivates the antibiotics neomycin and 
amikacin. These antibiotics are rarely routinely used during bone marrow transplantation or 
other medical care. The antibiotics routinely used are not inactivated, and these will be given to 
you to treat any bacterial infections that might occur. 
It is possible that multiple myeloma cells that may be present in your bone marrow or blood 
stream may also be infected with the neo^ gene. We will study this if your myeloma relapses. 
We do not believe you would be harmed should a multiple myeloma cell receive this neo^ - gene: 
D 
however, little information exists about this. It is possible that the neo^ gene could alter the 
multiple myeloma cell making it more or less malignant. It is also possible that the growth 
D 
factors used to put the neo^ gene into the bone marrow and blood cells could cause any 
myeloma cells to grow. We believe that these possibilities are unlikely to cause you any harm if 
they did happen, but we can’t be sure. There is also a small possibility that you could have an 
allergic reaction to the “marked” cells with the neo^ gene due to residual antibody that could be 
attached from the immunoadsorption column or residual growth factors that could be attached 
from the culture. We think it is unlikely that any small amount of antibody or growth factor 
attached to the cells would cause you any harm, including an allergic reaction, but it is 
theoretically possible. Should an allergic reaction occur, the physician present while you are 
receiving the cells will treat you for the reaction. 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-251 4-1 (10-84) 
NIH-251 4-2 (10-84) P.A.: 09-25-0099 
Recombinant DNA Research, Volume 16 
[85] 
