Table 1.
Pilot Phase Clinical Trials Evaluating Daratumumab in Patients with RRMM
| Study Name | Phase | N | Number of Prior Treatments | Regimen | Results |
|---|---|---|---|---|---|
| GEN501 | I–II | 104 | 4 | Dara monotherapy Dose escalation: 0.005–24 mg/kg Expansion phase:8 mg/kg and 16 mg/kg |
No MTD At 16 mg/kg dose: • ORR 36% (⩾PR) • 12-month OS: 77% • mPFS 5.6 months • 65% no progression at 12 months |
| SIRIUS | II | 106 | 5 | Dara monotherapy (16 mg/kg) |
• ORR 29.2% • 12-month OS: 64.8% • mPFS: 3.7 month |
| CASTOR | III | 499 | 2 | Arm 1: Dara-Vd Arm 2: Vd (control) |
• ↓risk of progression by 61% • ORR (⩾VGPR) 83.8% vs 63.2% • MRD negativity: 11.6% vs 2.4% • mPFS 16.7 vs 7.1 months |
| POLLUX | III | 569 | 1 | Arm 1: Dara-Rd Arm 2: Rd (control) |
• ORR (⩾VGPR) 92.9 vs 76.4% • MRD negativity 30.4% vs 5.3% • mPFS 44.5 vs 17.5 months OS: NR for either group |
Abbreviations: ORR, overall response rate; CR, complete response; VGPR, very good partial response; PR, partial response; Vd, Velcade–dexamethasone, Rd, Revlimid–dexamethasone; MRD, minimal residual disease, mPFS, median progression-free survival; OS, overall survival; MTD, maximum tolerated dose.