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8.1 Toxicity will be monitored and graded according to the 
Common Toxicity Criteria as given in the original 
protocol documents. 
8.2 Serious adverse effects occurring in any patients 
receiving genetically-marked cells will be reported 
immediately in writing to the NHLBI and NCI IRBs , ORDA, 
the RAC , the NIH Office for Protection from Research 
Risks, and the FDA. Other reporting of adverse events 
related to chemotherapy and autologous transplantation 
will be as described in the original protocols. 
8.3 Progress reports will be made to the RAC and to the IRB 
as requested at yearly intervals. 
9.0 CRITERIA FOR REMOVAL FROM AMENDMENT 
9.1 Criteria for removal from the original protocols due to 
disease progression are given in section 14.0 of the 
multiple myeloma and CML protocols, and section 6.13 of 
the breast cancer protocols. However, any patient that 
received transduced bone marrow or peripheral blood 
stem cells on this protocol amendment will be followed 
indefinitely, even if concurrently receiving other 
forms of therapy. 
9.2 Patient withdrawal: A patient may withdraw from the 
genetic marking amendment after bone marrow or 
peripheral blood harvest and transduction. In this 
circumstance, the patient will be given back the non- 
transduced cells alone (70%). Eligibility criteria 
ensure that enough non-transduced cells will available 
to ensure adequate hematopoietic reconstitution. 
10.0 RESPONSE ASSESSMENT AND IMPACT OF OUTCOME 
10.1 Response criteria to the clinical autologous 
transplantation protocols are given in sections 13.0 in 
the multiple myeloma and CML protocols, and section 
15.0 of the breast cancer protocol. 
10.2 Feasibility of Stem Cell Gene Transfer : A major 
objective of this pilot study is to study the 
feasibility of transducing human hematopoietic stem 
cells with a retroviral vector. Any evidence of long- 
term engraftment with marked cells will be of value in 
planning future therapeutic trials directed at these 
three diseases and at other malignant and genetic 
disorders. The probability of transducing a human stem 
cell is unknown. Primate data is not extensive enough 
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Recombinant DNA Research, Volume 16 
