Table 1.
Selected Clinical Trials of Daratumumab in Multiple Myeloma (MM)
| Trial ID (References) | Treatment | Phase | Enrollment (N) | Trial Title |
|---|---|---|---|---|
| NCT04656951 | Dara | II | 160 | Daratumumab for first Line treatment of transplant-ineligible myeloma patients followed by daratumumab re-treatment at first relapse (GMMG-DADA) |
| NCT0262648134 | Dara + Dex | II | 64 | A multicenter open label Phase II study of daratumumab in combination with dexamethasone in MM resistant or refractory to bortezomib and lenalidomide and pomalidomide |
| NCT0254138323,35 | Dara alone vs (Bort + Thal + Dex ± Dara) | III | 1085 | Study of daratumumab in combination with bortezomib, thalidomide, and dexamethasone (VTd) in the first line treatment of transplant eligible subjects with newly diagnosed MM (Cassiopeia) |
| NCT03993912 | (Len + Dex) vs (Len + Dex + Dara sc) | III | 294 | A phase III study comparing lenalidomide and subcutaneous daratumumab (R-dara sc) vs lenalidomide and dexamethasone (Rd) in frail subjects with previously untreated MM who are ineligible for high dose therapy |
| NCT0231610636 | Dara | II | 123 | A randomized phase II trial to evaluate three daratumumab dose schedules in smoldering MM |
| NCT0315868826,37,38 | (Carf + Dex) ± Dara | III | 466 | A randomized, open-label, phase III study comparing carfilzomib, dexamethasone, and daratumumab to carfilzomib and dexamethasone for the treatment of patients with RRMM (CANDOR) |
| NCT0213613421,39 | (Bort + Dex) ± Dara | III | 499 | Phase III study comparing daratumumab, bortezomib and dexamethasone (DVd) vs bortezomib and dexamethasone (Vd) in subjects with RRMM (CASTOR) |
| NCT0330122040 | Dara sc + Hyal | III | 390 | A phase III randomized, multicenter study of subcutaneous daratumumab versus active monitoring in subjects with high-risk smoldering MM (AQUILA) |
| NCT03901963 | Len ± Dara | III | 214 | A randomized study of daratumumab plus lenalidomide versus lenalidomide alone as maintenance treatment in patients with newly diagnosed MM who are minimal residual disease positive after frontline ASCT |
| NCT0207600922,41,42 | (Len + Dex) ± Dara | III | 569 | Phase III study comparing daratumumab, lenalidomide, and dexamethasone (DRd) vs lenalidomide and dexamethasone (Rd) in subjects with RRMM (POLLUX) |
| NCT0318073643 | (Pom + Dex) ± Dara | III | 304 | A phase III study comparing pomalidomide and dexamethasone with or without daratumumab in subjects with RRMM who have received at least one prior line of therapy with both lenalidomide and a proteasome inhibitor (Apollo) |
| NCT04649060 | Dara ± Melf | III | 240 | A randomized, controlled, open-label phase III study of melflufen in combination with daratumumab compared with daratumumab in patients with RRMM (LIGHTHOUSE) |
| NCT0225217244,45 | (Len + Dex) ± Dara | III | 737 | A phase III study comparing daratumumab, lenalidomide, and dexamethasone (DRd) vs lenalidomide and dexamethasone (Rd) in subjects with previously untreated MM who are ineligible for high dose therapy (MAIA) |
| NCT03652064 | (Bort + Len + Dex) ± Dara | III | 395 | A phase III study comparing daratumumab, bortezomib, lenalidomide, and dexamethasone (D-VRd) with bortezomib, lenalidomide, and dexamethasone (VRd) in subjects with untreated MM and for whom ASCT is not planned as initial therapy |
| NCT0327710546–48 | Dara (sc vs iv) | III | 522 | A phase III randomized, multicenter study of subcutaneous vs intravenous administration of daratumumab in subjects with RRMM (COLUMBA) |
Abbreviations: Bort, bortezomib; Carf, carfilzomib; Dara, daratumumab; Dex, dexamethasone; Hyal, hyaluronidase; iv, intravenous; Len, lenalidomide; Melf, melflufen; Pom, pomalidomide; sc, subcutaneous; Thal, thalidomide.