Table 2.
Main ongoing trials involving daratumumab and isatuximab in multiple myeloma patients.
| Study | Setting | Phase | Study Design |
|---|---|---|---|
| DARATUMUMAB | |||
| NCT03710603 [46] | NDMM TE (690 pts) |
III | Dara-VRd + ASCT + Dara-VRd consolidation + Dara-R maintenance vs. VRd + ASCT + VRd consolidation + R maintenance |
| NCT03896737 | NDMM TE (≈400 pts) |
II | Dara-VCd + double ASCT + Dara-VCd consolidation vs. VTd + double ASCT + VTd consolidation Second randomization: Ixa maintenance vs. Ixa-Dara |
|
NCT03180736 |
RRMM (302 pts) |
III | Dara-Poma-dex vs. Poma-dex |
| NCT03158688 | RRMM (466 pts) |
III | Dara-Kd vs. Kd |
| ISATUXIMAB | |||
| NCT02513186 [47,48] | NDMM NTE (88 pts) |
I/II | Isa-VCd vs. Isa-VRd |
| NCT03319667 [49] | NDMM, NTE (475 pts) |
III | Isa-VRd vs. VRd |
| NCT03275285 | RRMM (302 pts) |
III | Isa-Kd vs. Kd |
| NCT02990338 [50] | RRMM (300 pts) |
III | Isa-Poma-dex vs. Poma-dex |
Abbreviations: pts, patients; NDMM, newly diagnosed multiple myeloma; RRMM, relapsed/refractory MM; Dara, daratumumab; Isa, isatuximab; ASCT, autologous stem-cell transplantation; TE, transplant eligible; NTE, transplant ineligible; Ixa, ixazomib; V, bortezomib; C, cyclophosphamide; d, dex, dexamethasone; T, thalidomide; R, lenalidomide; K, carfilzomib; Poma, pomalidomide.