Table 5.

Dose reductions in patients receiving bortezomib and PegLD


Bortezomib dose level, mg/m2

Drug reduced (dose in mg/m2)

Cycle and day*

Reason
1.05   PegLD (to 22.5)   c4, d4   PPE/HFS 
1.30  Bortezomib (to 1.05)   c4, d1   Decreased quality of life  
1.30  Bortezomib (to 1.05)   c5, d1   Peripheral neuropathy  
1.40   Bortezomib (to 1.05)   c3, d1   Thrombocytopenia  
1.50   Bortezomib (to 1.30)   c3, d8   Peripheral neuropathy  
1.50   Bortezomib (to 1.05)   c4, d8   Diarrhea and fatigue  
1.50   Bortezomib (to 1.30)   c6, d8   Diarrhea and nausea  
1.50   Bortezomib (to 1.30)   c3, d1   Peripheral neuropathy  
1.50
 
PegLD (to 22.5)
 
c3, d1
 
PPE/HFS
 

Bortezomib dose level, mg/m2

Drug reduced (dose in mg/m2)

Cycle and day*

Reason
1.05   PegLD (to 22.5)   c4, d4   PPE/HFS 
1.30  Bortezomib (to 1.05)   c4, d1   Decreased quality of life  
1.30  Bortezomib (to 1.05)   c5, d1   Peripheral neuropathy  
1.40   Bortezomib (to 1.05)   c3, d1   Thrombocytopenia  
1.50   Bortezomib (to 1.30)   c3, d8   Peripheral neuropathy  
1.50   Bortezomib (to 1.05)   c4, d8   Diarrhea and fatigue  
1.50   Bortezomib (to 1.30)   c6, d8   Diarrhea and nausea  
1.50   Bortezomib (to 1.30)   c3, d1   Peripheral neuropathy  
1.50
 
PegLD (to 22.5)
 
c3, d1
 
PPE/HFS
 
*

The cycle (c) and day (d) at which reductions were pursued are indicated after the respective abbreviations. In the first case at 1.50, a patient had 2 separate bortezomib dose reductions, whereas in the last case, both bortezomib and PegLD were reduced concomitantly.

Both dose reductions at 1.30 mg/m2 occurred in the expanded cohort at this level and these data therefore did not contribute to the determination of a dose recommended for further study.

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