Start Date
December 22, 2021
Primary Completion Date
July 5, 2023
Study Completion Date
July 5, 2023
Tazemetostat
Orally, twice daily in continuous 28-day cycles.
Tafasitamab
Intravenously, 12 mg/kg, once daily on Cycle 1: Days 1, 4, 8, 15 and 22 of the 28-day cycle. Cycles 2 and 3: Days 1, 8, 15 and 22 of each 28-day cycle. Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle.
Lenalidomide
Orally, 10 mg or 20 mg based on kidney function, once daily from Days 1 to 21 of continuous 28-day cycles for up to 12 cycles.
Acalabrutinib
Orally, 100 mg, twice daily.
Daratumumab (Intravenously)
Intravenously, 16 mg/kg actual body weight, once daily on Cycles 1 and 2: Days 1, 8, 15 and 22 of the 28-day cycle. Cycles 3 through 6: Days 1 and 15 each 28-day cycle. Cycle 7 and beyond: Day 1 of each 28-day cycle.
Mosunetuzumab
Subcutaneously, step-up doses on Cycle 1 Days 1 (5 mg), 8 (45 mg) and 15 (45 mg) and then 45 mg from Cycle 2 through 12 on Day 1 of the 28-day cycle.
Daratumumab (Subcutaneously)
Subcutaneously, 1800 mg, once daily on Cycles 1 and 2: Days 1, 8, 15 and 22 of the 28-day cycle. Cycles 3 through 6: Days 1 and 15 each 28-day cycle. Cycle 7 and beyond: Day 1 of each 28-day cycle.
Hyaluronidase-Fihj
Subcutaneously, 30,000 units, once daily on Cycles 1 and 2: Days 1, 8, 15 and 22 of the 28-day cycle. Cycles 3 through 6: Days 1 and 15 each 28-day cycle. Cycle 7 and beyond: Day 1 of each 28-day cycle.
Pomalidomide
Orally, 4 mg, once daily on Days 1 to 21 of continuous 28-day cycles.
Dexamethasone 20mg
Orally, 20 mg or 40 mg, once daily on Days 1, 8, 15, and 22 of continuous 28-day cycles.
Central Care Cancer Center, Bolivar
California Cancer Associates For Research And Excellence, cCARE, Santa Fe
Astera Cancer Center, East Brunswick
Lead Sponsor
Epizyme, Inc.
INDUSTRY