Table 3.
Ongoing clinical trials of subcutaneous daratumumab in multiple myeloma.
| NCT number | Title | Phase | n | Recruitment |
|---|---|---|---|---|
| Newly diagnosed multiple myeloma | ||||
| NCT03993912 | A phase III study comparing lenalidomide and Dara-SC (R-Dara-SC) versus lenalidomide and dexamethasone (Rd) in frail subjects with previously untreated multiple myeloma who are ineligible for high dose therapy | III | 294 | Recruiting |
| NCT04052880 | A phase II study of Dara-SC in combination with dose-attenuated bortezomib, lenalidomide, and dexamethasone in elderly newly diagnosed multiple myeloma patients | II | 38 | Recruiting |
| NCT04151667 | Phase II study of daratumumab based response adapted therapy for older adults with newly diagnosed multiple myeloma | II | 32 | Recruiting |
| NCT03710603 | A phase III study comparing daratumumab, VELCADE (bortezomib), lenalidomide, and dexamethasone (D-VRd) versus VELCADE, lenalidomide, and dexamethasone (VRd) in subjects with previously untreated multiple myeloma who are eligible for high-dose therapy (PERSEUS) | III | 690 | Active, not recruiting |
| NCT03652064 | A phase III study comparing daratumumab, VELCADE (bortezomib), lenalidomide, and dexamethasone (D-VRd) with VELCADE, lenalidomide, and dexamethasone (VRd) in subjects with untreated multiple myeloma and for whom hematopoietic stem cell transplant is not planned as initial therapy | III | 395 | Active, not recruiting |
| NCT03901963 | A randomized study of daratumumab plus lenalidomide versus lenalidomide alone as maintenance treatment in patients with newly diagnosed multiple myeloma who are minimal residual disease positive after frontline autologous stem cell transplant (AURIGA) | III | 214 | Recruiting |
| NCT04497961 | Daratumumab versus lenalidomide maintenance therapy for multiple myeloma: a randomized pilot study comparing patient-reported health related quality of life measures | II | 100 | Not yet recruiting |
| Relapsed refractory multiple myeloma | ||||
| NCT03180736 | A phase III study comparing pomalidomide and dexamethasone with or without daratumumab in subjects with relapsed or refractory multiple myeloma who have received at least one prior line of therapy with both lenalidomide and a proteasome inhibitor (APOLLO) | III | 304 | Active, not recruiting |
| NCT03314181 | A phase I/II, multicenter, dose-escalation and expansion study of combination therapy with venetoclax, daratumumab and dexamethasone (with and without bortezomib) in subjects with relapsed or refractory multiple myeloma | II | 104 | Recruiting |
| NCT03871829 | A phase II study of Dara-SC administration in combination with carfilzomib and dexamethasone (DKd) compared with carfilzomib and dexamethasone (Kd) in participants with multiple myeloma who have been previously treated with Dara-IV to evaluate daratumumab retreatment | II | 230 | Recruiting |
| Novel combinations | ||||
| NCT04108195 | A phase Ib study of subcutaneous daratumumab regimens in combination with bispecific T-cell redirection antibodies for the treatment of subjects with multiple myeloma | II | 100 | Recruiting |
| NCT03837509 | A randomized open-label phase I/II study of INCB001158 combined with Dara-SC, compared with Dara-SC, in participants with relapsed or refractory multiple myeloma | I/II | 98 | Recruiting |
| Smoldering myeloma | ||||
| NCT03301220 | A phase III randomized, multicenter study of subcutaneous daratumumab versus active monitoring in subjects with high-risk smoldering multiple myeloma | III | 389 | Active, not recruiting |
Dara-IV, intravenous daratumumab; Dara-SC, subcutaneous daratumumab; NCT, National Clinical Trial.