2.2 
GENERAL PROTOCOL OUTLINE: 
3-12 months 
1. Standard induction or salvage chemotherapy. 
Patient must demonstrate a response defined as a 
50% reduction in serum paraprotein or a 90% 
reduction in urine paraprotein. 
> 1 month 
2. Marrow recovery period from prior chemotherapy 
or interferon. 
2-3 weeks 
3. Peripheral blood stem cell mobilization and 
harvest. 
Day 1: Cyclophosphamide X 1 
Day 2 until harvest complete: G-CSF 
Day when WBC reaches 1,000/ul: Begin daily 
apheresis harvesting of- mononuclear cells, 
continue until 3 X 10 8 cells/kg obtained. 
> 2 weeks 
4. Recovery from peripheral stem cell mobilization 
10 days 
5. Marrow priming and harvest: 
Day 1-3: 5-f luorouracil 
Day 10: Bone marrow harvest of at least 0.5 X 
10 8 cells/kg 
> 2 days 
6. Recovery from bone marrow harvest 
4 days 
7. Marrow ablation and transplant: 
Day -4 to Day 0: High-dose melphalan +/- 
total body irradiation 
Day 0: Marrow and peripheral blood stem cell 
reinfusion 
3-6 weeks 
7 . Administer G-CSF and aggressive supportive 
care until marrow recovery. 
Marrow 
Recovery 
8. Begin interferon maintenance 
9. Monitor bone marrow function and disease status 
until relapse or indefinitely if the patient 
remains in remission. 
2.3 THERAPEUTIC JUSTIFICATION FOR THIS TREATMENT PLAN: As we 
will discuss in much more detail. -in section 3.0, high-dose 
therapy with autologous or allogeneic bone marrow rescue has 
been shown in several small preliminary studies to have a 
unique ability to produce complete disappearance of the 
• abnormal myeloma paraprotein in a majority of patients. 2,3 
This is indicative of a much lower residual tumor mass post- 
transplantation than after standard chemotherapy, which 
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