Table 1

Patient disposition by dose level in the phase 1 and phase 2 portions, and number of patients experiencing DLT*

Dose levelLenalidomide dose, mg/dBortezomib dose, mg/m2Dexamethasone dose, mgPLD dose, mg/m2No. of patients enrolledDLT, n
Phase 1: Dose escalation (n = 40)       
    1 15 1.3 20 20 
    2 20 1.3 20 20 10 
    3 25 1.3 20 20 19 
    4 25 1.3 20 30 
Phase 2: After MTD determination (n = 32)       
    4 25 1.3 30 30 32 NA 
Dose levelLenalidomide dose, mg/dBortezomib dose, mg/m2Dexamethasone dose, mgPLD dose, mg/m2No. of patients enrolledDLT, n
Phase 1: Dose escalation (n = 40)       
    1 15 1.3 20 20 
    2 20 1.3 20 20 10 
    3 25 1.3 20 20 19 
    4 25 1.3 20 30 
Phase 2: After MTD determination (n = 32)       
    4 25 1.3 30 30 32 NA 

NA indicates not applicable.

*

Two patients were not evaluable for DLT per protocol and were replaced.

20 mg/d dexamethasone cycles 1-4 and 10 mg/d dexamethasone cycles 5-8 and maintenance.

Including 7 patients treated at level 4 (MTD).

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