Determination of the MTD during phase 1
Dose level . | Carfilzomib dose, mg/m2 . | N = 35 . | n . | DLT probablilty estimate* . | 95% Credible interval . |
---|---|---|---|---|---|
1 | 20 | 4 | 0 | 5.9% | 1.7-15.3 |
2 | 27 | 13 | 1† | 8.1% | 2.6-19.4 |
3 | 36 | 18 | 2‡ | 12.0% | 4.3-25.4 |
Dose level . | Carfilzomib dose, mg/m2 . | N = 35 . | n . | DLT probablilty estimate* . | 95% Credible interval . |
---|---|---|---|---|---|
1 | 20 | 4 | 0 | 5.9% | 1.7-15.3 |
2 | 27 | 13 | 1† | 8.1% | 2.6-19.4 |
3 | 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.