Table 2.
Pivotal clinical trials of subcutaneous daratumumab (Dara-SC).
| Study | Trial name [ClinicalTrials.gov identifier] | Phase | n | Regimen (dose) | ORR (%) | IRR (%) |
|---|---|---|---|---|---|---|
| Clinical trials with Dara-SC in RRMM | ||||||
| Usmani et al.15 | PAVO [NCT02519452] | I/II | 8 | Daratumumab-MD (1200 mg)a | 25% | 13% |
| 45 | Daratumumab-MD (1800 mg)a | 42% | 24% | |||
| 25 | Dara-SC (1800 mg)b | 52% | 16% | |||
| Mateos et al.14 | COLUMBA [NCT03277105] | III | 522 | Dara-SC (1800 mg) versus IV | 41% versus 37% | 13% versus 35% |
| Chari et al.16 | PLEAIDES [NCT03412565] | II | 65 | Dara-SC (1800 mg) + Rd | 94% | 5% |
| Clinical trials with Dara-SC in NDMM | ||||||
| Chari et al.16 | PLEAIDES [NCT03412565] | II | 67 | Dara-SC (1800 mg) + VRd* | 97% | 9% |
| 67 | Dara-SC (1800 mg) + VMP** | 90% | 9% | |||
*
Transplant eligible.
**
Transplant ineligible.
a
Part 1 of PAVO using mix-and-deliver formulation.
b
Part 2 of PAVO using premixed formulation.
d, dexamethasone; Dara-SC, subcutaneous daratumumab; IRR, infusion-related reaction; IV, intravenous; M, melphalan; MD, mix and deliver; NCT, National Clinical Trial; NDMM, newly diagnosed multiple myeloma; ORR, overall response rate; P, prednisone; PFS, progression-free survival; R, lenalidomide; RRMM, relapsed/refractory multiple myeloma; SC, subcutaneous; V, bortezomib.