Table 2

Determination of the MTD during phase 1

Dose levelCarfilzomib dose, mg/m2N = 35nDLT probablilty estimate*95% Credible interval
20 5.9% 1.7-15.3 
27 13 1 8.1% 2.6-19.4 
36 18 2 12.0% 4.3-25.4 
Dose levelCarfilzomib dose, mg/m2N = 35nDLT probablilty estimate*95% Credible interval
20 5.9% 1.7-15.3 
27 13 1 8.1% 2.6-19.4 
36 18 2 12.0% 4.3-25.4 

DLT indicates dose-limiting toxicities; and MTD, maximum tolerated dose.

*

Time-to event continual reassessment method single-parameter logistic model.

Neutropenia, grade 3, asymptomatic, resolved within a few days.

One patient with grade 4 pulmonary edema; it resolved with diuresis but the patient withdrew consent and switched to alternate therapy achieving CR; the second patient with grade 3 dyspnea responded to diuresis and resumed treatment at a lower carfilzomib dose level; the patient continued on this dose without difficulty in subsequent cycles.

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