MEDICAL RECORO 
CONTINUATION SHEET for either: 
NIH 2514-1, 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 6_of 12 _ pages. 
blood cells are returned to you, you will be treated with very 
high-dose chemotherapy and radiation. These treatments are an 
attempt to completely eliminate your remaining tumor cells. 
They can cause a number of side effects, all or some of which 
you will experience. Attempts will be made to minimize these 
side efffects as much as possible. 
You will receive one intravenous injection of a drug called 
melphalan five days before the transplant. This drug has 
been used at low doses in an oral form for twenty-five years 
in multiple myeloma. The intravenous form is an 
investigational drug but has been given to over 200 patients 
at high doses prior to bone marrow transplant. High-dose 
melphalan is associated with hair loss, nausea and vomiting, 
sores in the mouth, skin rashes, diarrhea, and low blood 
counts. 
One day after receiving .the melphalan, you will begin 
radiation treatments to .your entire body (total body 
irradiation or TBI). Radiation will be given in six doses 
over three days. This, type of radiation treatment almost 
always causes nausea, vomiting, diarrhea, mouth sores and 
fatigue. Rarely it can cause serious lung damage, cataracts 
(clouding of the eyes), sterility, and an increased risk of 
another type of cancer* later in life.. 
If you have previously received extensive radiation treatments 
to your back, lungs, hips or pelvis for myeloma bone tumors, 
you may not be able to receive the total body irradiation 
because of the high risk of damage to your internal organs 
from further radiation treatments. In that case, we would not 
give you the total body irradiation but instead would give you 
an even higher dose of the melphalan by itself. It is 
possible that your risk of relapse after the transplant will 
be higher if you do not receive the total body irradiation. 
6) Bone Harrow and Peripheral Blood Stem Cell Reinfusion: One 
day after completing radiation treatments, you will receive 
your stored bone marrow and peripheral blood stem cells back. 
The frozen cells will be thawed at the bedside and given back 
to you through an intravenous line. The side effects of this 
infusion include an unpleasant garlic-like taste in your 
mouth due to a substance called DMSO that the cells were 
frozen in. Some patients also experience temporary shortness 
of breath and pain or coldness at the intravenous site. Your 
'PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
NIH-2S14-1 (10-84) 
Recombinant DNA Research, Volume 16 
[75] 
