Table 2. . Dosing regimens.
Drug | Dose level | (Cycle 1 is 35 days; remainder are 28 days) | ||
---|---|---|---|---|
Cycle 1 | Cycle 2 | Cycle 3+ | ||
Magrolimab | Starting dose | Priming dose: day 1 Maintenance dose: days 8, 15, 22, 29 |
Maintenance dose: days 1, 8, 15, 22 | Maintenance dose: day 1, 15 |
Daratumumab† | 16 mg/kg iv. or 1800 mg sc. |
Days 8, 15, 22, 29 | Days 1, 8, 15, 22 | Days 1, 15 for cycles 3 to 6; day 1 of cycles 7+ |
Pomalidomide | 4 mg p.o. | Days 1 to 21 daily | Days 1 to 21 daily | Days 1 to 21 daily |
Carfilzomib‡ | 20/70 mg/m2 iv. | Days 8 (20 mg/m2), 15 (70 mg/m2), 22 (70 mg/m2) | Days 1, 8, 15 | Days 1, 8, 15 |
Bortezomib | 1.3 mg/m2 sc./iv.§ | Days 8, 15, 22, 29 | Days 1, 8, 15, 22 | Days 1, 8, 15, 22¶ |
Dexamethasone | 40 mg p.o. | Days 1, 8, 15, 22, 29# | Days 1, 8, 15, 22 | Days 1, 8, 15, 22†† |
This arm will not receive treatment with dexamethasone.
Recommended starting dose is 20 mg/m2 on cycle 1, day 8. If tolerated, escalate dose to 70 mg/m2 on cycle 1, day 15 and thereafter.
sc. is preferred over iv., where feasible.
Maximum of 8 cycles in those who previously received bortezomib.
Administration on day 1 does not occur in the carfilzomib cohort.
Those patients in the magrolimab + carfilzomib + dexamethasone group will receive dexamethasone on days 1, 8, 15 and 22 from cycle 2 until cycle 9 and days 1, 8 and 15 from cycle 10 onward.
iv.: Intravenous; p.o.: Oral; sc.: Subcutaneous.