MfcUlUAL HbCJOHU 
CONSENT TO PARTICIPATE IN' A CLINICAL RESEARCH* * STUDY 
• Adult Patient or * Parent, for Minor Patient 
INSTITUTE: NATIONAL HEART. LUNG AND BLOOD INSTITUTE 
STUDY NUMBER: PRINCIPAL INVESTIGATOR: Cvnthia Dunbar. M.D. 
STUDY TITLE: Informed Consent for Retroviral-Mediated Gene Transfer of Bone Marrow 
and Peripheral Blood Stem Cells During Autologous Bone Marrow Transplantation for Multiple 
Myeloma 
INTRODUCTION 
We invite you 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 that take part 
in our studies: (a) taking part in the study is entirely voluntary; (b) personal benefit will not 
result from taking part in this 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 may have about this study with the staff members who explain it to you. 
NATURE OF STUDY 
Autologous bone marrow transplantation is a treatment with potential benefit for patients 
with multiple myeloma. Autologous bone marrow transplantation and its risks have been 
explained to you in a separate Informed Consent document and you have agreed to be enrolled in 
our transplantation protocol. You are now also being asked to take part in a research study of 
"retroviral-mediated gene transfer" of bone marrow cells and peripheral blood stem cells used 
during autologous bone marrow transplantation. The intent of this protocol is to treat you with 
high dose chemotherapy and to then give back the bone marrow and circulating blood cells that 
have been removed from you. Part of the bone marrow and circulating cells will have been 
“marked” with a special gene as described below. The goal of the study is to determine whether 
it is possible to put a new gene into bone marrow or circulating blood cells that will stay in your 
body for several months or more. It is not yet known whether it is possible to successfully place 
new genes into patients’ bone marrow or circulating blood cells and to have the genes stay in 
these cells over several months to years. If this could be accomplished, it would represent an 
important potential advance in the treatment of many diseases. We may also learn important 
information that could improve the safety and usefulness of autologous transplantation in 
multiple myeloma. 
You are being asked to take part in a research study that will try and accomplish the 
R 
placement of a bacterial gene called neo^ into your bone marrow and circulating blood cells. An 
important part of the study involves testing bone marrow and circulating blood cells periodically 
to see whether the neo^ gene is in these cells and how long the gene stays in the cells. The new 
technology to be used in this research study is called "retroviral-mediated gene transfer". It will 
be used to put a (neo^) gene into some of your bone marrow cells and peripheral blood stem 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
RESEARCH STUDY 
• Adult Patient or ‘Parent, for Minor Patient 
[82] 
Recombinant DNA Research, Volume 16 
