Full Efficacy & Safety Summary Table
Indication | In combination with dexamethasone for relapsed MM following at least 4 prior lines of therapy |
Registrational Trial | Accelerated Approval. Phase 2 Single Arm OCEAN trial (n=157) (NCT03151811) |
Regimen | 40 mg administered intravenously over 30 minutes on Day 1 of each 280 day cycle until disease progression or until acceptable toxicity |
Efficacy Outcomes | ORR: 23.70% OS: 9.1 months DOR: 4.2 months PFS: 3.8 months |
Safety Outcomes | Gr 3/4 ARs (≥2%): Pneumonia 11%, Fatigue 6%, Respiratory Tract Infection 5% Dose Reduction: 27% Discontinuation: 22% |