count reaches 1000/ul. On the day after the collection 
is > 1 X 10® nucleated cells/kg for the first time, the 
patient will be eligible for genetic marking of that 
day's collection. Aphereses will be done daily until 
at least 3 X 10® total nucleated cells/kg have been 
collected. Only one day's collection will be 
genetically marked. If no collection is > 1 X 10®/kg / 
then the patient will receive daily aphereses without 
genetic marking until 3 X 10® total nucleated cells/kg 
have been collected. 
4.2 Adequacy of Bone Marrow Harvest : A minimum of 1 X 10® 
nucleated buffy coat cells/kg (post-processing) must be 
harvested in order for genetic marking to be performed. 
If less than this number is obtained, the patient will 
not have genetic marking of the marrow. Whether or not 
the patient will go on to autologous transplantation 
without genetic marking will then be determined by 
engraftment and safety criteria in the original 
protocols. An additional bone marrow harvest may be 
carried out at the discretion of the investigator. 
4.3 Enrollment : We expect to enroll approximately 40 
patients in the genetic marking protocol amendment over 
three years. Approximately 12-16 would be entered in 
each of the three clinical protocols (multiple myeloma, 
chronic myelogenous leukemia, and breast cancer). A 
portion of the multiple myeloma and chronic myelogenous 
leukemia patients will be treated on an identical 
genetic marking ammendemnt at the University of 
Virginia Medical Center, after approval by their IRB. 
5.0 Genetic Marking Treatment Plan 
5.1 Peripheral Blood Stem Cells : (Multiple Myeloma and CML 
Protocols only) If criteria are met as described in 
section 4.1, the peripheral blood stem cells collected 
on day 2 will be transduced. The remaining peripheral 
blood stem cells collections will not be transduced but 
will be immediately processed and cryopreserved as 
described in the original protocols. This approach will 
result in at least 70% of the collected PBSCs being 
saved without transduction, and less than 30% being 
transduced. 
The PBSCs available for transduction will be incubated 
with the anti-CD34 murine monoclonal antibody 12.8 and 
then passed over the CellPro immunoadsorption column 
(see Appendix B for details of the procedure). The 
CD34+ enriched cell population will be cultured in 
vitro for 72 hours in the presence of either the LNL6 
Recombinant DNA Research, Volume 16 
