two assays post-transplantation, separated by at least 4 
weeks, and less than 5 % piasma cells on bone marrow 
aspiration. The first assessment for response will occur at 
three months post-transplant. 
The persistence of a detectable allele-specif ic- - 
immunoglobulin gene rearrangement marker on PCR of post- 
transplantation marrow or peripheral- blood -DNA' will not 
preclude a clinical CR, but will be required for a complete 
genetic response (CGR) . 
13.2 A partial clinical response (PR) will" be 'defined as a 
> 50% reduction in the serum monoclonal immunoglobulin 
biomarker, or a greater than 90% reduction in the urine 
monoclonal light chain biomarker on at least two assays 
post-transplantation, separated by at least 4 weeks, and a 
greater than 50% reduction in bone marrow plasma cells. 
13.3 Patients not achieving a PR or a CR will be considered 
clinical non-responders (NR) . 
14.0 CRITERIA FOR REMOVAL FROM STUDY 
14.1 Disease progression as defined as a greater than 25% 
increase in M-protein level over M-protein at entry 
into the study, progressive bone marrow failure due to 
plasma cell infiltration, or progressive lytic bone 
lesions. 
14.2 Location of a compatible donor and proceeding to 
allogeneic marrow transplant. 
14.3 Pregnancy. 
14.4 Patient withdrawal.. Withdrawal after melphalan and TBI 
but before- stem cell reinfusion will almost 
certainly lead to death. 
15-.0 BIOSTATISTICAL ANALYSIS 
15. 1. Evaluation ' of Clinical/Morphologic Response to 
Treatment Process: 
Continued study of -this- treatment approach is warranted 
if this study shows a partial or complete remission 
sustained at" least 6 months in > 30% of patients. 
Initially, 14 patients will be studied. If < 2 patients 
meet these criteria, the study would close. If > 3 
patients achieve' complete'remission, a total of 25 
patients would be studied. Under these conditions there 
’ is a 90% probability that- the -study will continue with 
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Recombinant DNA Research, Volume 16 
