Table 1.
Ongoing clinical trial with daratumumab in transplant eligible newly diagnosed MM patients.
| Trial | Phase | Characteristics of patients | Design | ClinicalTrials N. |
|---|---|---|---|---|
| MUK Nine b: OPTIMUM Treatment Protocol (MUKnineb) | II | Transplant eligible with high-risk NDMM and plasma cell leukemia | CVRDd × 4-6 (induction)→SCT→DVRd x 6 (consolidation part 1) → DVR × 12 (consolidation part 2)→DR (maintenance) | 03188172 |
| Study association of lenalidomide, ixazomib, dexamethasone and daratumumab in newly diagnosed standard risk multiple myeloma (IFM2018-01) | II | Transplant eligible with standard-risk NDMM | IxaRd-D (induction) → SCT → IxaRdD (consolidation) → R (maintenance) | 03669445 |
| Daratumumab, carfilzomib, lenalidomide, and low dose dexamethasone (DKRd) in newly diagnosed, multiple myeloma | II | Transplant and non-transplant eligible NDMM | DKRd x 24 cycles | 03500445 |
| Ixazomib citrate, lenalidomide, dexamethasone, and daratumumabintreating patients with newly diagnosed multiple myeloma | II | Transplant and non-transplant eligible NDMM | IxaRdD × 12 (induction) → IxaD for up to 36 months (maintenance) | 03012880 |
| Daratumumab, ixazomib, and dexamethasone or daratumumab, bortezomib, and dexamethasone in patients with newly diagnosed multiple myeloma (DeRIVE) | II | Transplant and non-transplant eligible NDMM | Arm 1: IxaDd x 8 (induction) → ± SCT → IxaDd for up to 24 months (maintenance) Arm 2: DVd x 3 followed by IxaDd x 5 (induction) → ± SCT → IxaDd for up to 24 months (maintenance) |
03944224 |
| An intensive program with with quadruplet induction and consolidation plus tandem autologous stem cell transplantation in newly diagnosed high-risk multiple myeloma patients (IFM 2018-04) | II | Transplant eligible with high-risk NDMM | DKRd × 6 (induction) → tandem SCT → DKRd × 4 (consolidation) → DR (maintenance) | 03606577 |
| Study of daratumumab combined with carfilzomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma | II | Transplant and non-transplant eligible NDMM | DKRd x 8 (induction) → MRD based therapy (post-induction) | 04113018 |
| 2015-12: A study exploring the use of early and late consolidation/maintenance therapy | II | Transplant eligible with high-risk NDMM | DKTd-PACE ×→ SCT → DKd ± SCT (consolidation 1) → D (consolidation 2) → DKd alternating with DRd in 3-month blocks | 03004287 |
| Adaptive strategy in treatment for newly diagnosed multiple myeloma with upfront daratumumab-based therapy | II | Transplant and non-transplant eligible NDMM | DRd (induction) → DVRd (consolidation MRD based) → DR→R (maintenance) | 04140162 |
| Daratumumab in treating transplant-eligible partecipants with multiple myeloma | II | Transplant eligible with NDMM who have received any prior induction therapy | D × 2 (consolidation 1) → SCT (consolidation 2) → DR × 12→D (maintenance) | 03477539 |
| Short course daratumumab in patients with multiple myeloma | II | Transplant with NDMM who have achieved VGPR or better after induction ± consolidation/SCT | DR × 6 months | 03490344 |
| A study of daratumumab plus lenalidomide versus lenalidomide alone as maintenance treatment in participants with newly diagnosed multiple myeloma who are minimal residual disease positive after frontline ASCT (AURIGA) | III | Transplant eligible with NDMM who have received induction ± consolidation and SCT | DR vs R until progression | 03901963 |
| S1803, daratumumab/rHuPh20+/− lenalidomide as post-ASCT maintenance for MM w/MRD to direct therapy duration (DRAMATIC) | III | Transplant eligible with NDMM who have received induction and SCT | DR vs R, duration guided by MRD status | 04071457 |
C, cyclophosphamide; V, bortezomib; R, lenalidomide; D, daratumumab; d, dexamethasone; Ixa, ixazomib; K, carfilzomib; T, thalidomide; SCT, stem cell transplant.