Table V.
Dose level | Mitoxantrone | Etoposide | Cytarabine | Midostaurin | Bortezomib | Number Treated | Number Replaced | Number of DLTs |
---|---|---|---|---|---|---|---|---|
1 | - | - | - | 50 mg BID PO d 1–14 | 1.0 mg/m2 IV d 1,4,8,11 | 6 | 0 | 0 |
2 | - | - | - | 50 mg BID PO d 1–14 | 1.3 mg/m2 IV d 1,4,8,11 | 5 | 2A | 0 |
3 | 4 mg/m2 IV d 1–6 | 40 mg/m2 IV d 1–6 | 1 g/m2 IV d 1–6 | 50 mg BID PO d 8–21 | 1.3 mg/m2 IV d 8,11,15,18 | 3 | 1 | |
3* | 4 mg/m2 IV d 1–6 | 40 mg/m2 IV d 1–6 | 1 g/m2 IV d 1–6 | 50 mg BID PO d 8–21 | 1.3 mg/m2 SQ d 8,11,15,18 | 6 | 3 | |
3A | 4mg/m2 IV d 1–6 | 40mg/m2 IV d 1–6 | 1 g/m2 IV d 1–6 | 50mg BID PO d 8–21 | 1.0 mg/m2 SQ d 8 and 15 | 8 | 1B | 2 |
4 | 6 mg/m2 IV d 1–6 | 80 mg/m2 IV d 1–6 | 1 g/m2 IV d 1–6 | 50 mg BID PO d 8–21 | 1.3 mg/m2 SQ d 8 and 15 | 6 | 3C | 2 |
One patient developed sepsis on day 10 of cycle 1 and treatment was held. One patient withdrew consent on day 2 of therapy to pursue supportive care.
The patient withdrew consent on day 14 of therapy for non-treatment related reasons.
One patient developed sepsis on day 12 of therapy and treatment was held. One patient had doses held beginning on day 18 while undergoing evaluation for a possible ileus. One patient refused to continue treatment on day 19 of therapy because of grade 2 nausea.