Selected ongoing and planned studies with CD38-targeting antibody-containing regimens in newly diagnosed MM or smoldering MM
| Study . | Phase . | Patients . | Treatment . |
|---|---|---|---|
| NCT02316106 (Centaurus) | 2 | Intermediate or high-risk smoldering MM | 3 dose schedules of daratumumab as single agent (short, intermediate, and long treatment duration) |
| NCT02960555 | 2 | High-risk smoldering MM | Isatuximab as single agent |
| Cassiopeia (IFM 2015-01; HOVON 131; NCT02541383) | 3 | NDMM, transplant eligible | Randomization 1: VTD induction therapy, followed by high-dose melphalan plus autologous stem cell rescue, followed by VTD consolidation vs VTD with daratumumab induction therapy, followed by high-dose melphalan plus autologous stem cell rescue, followed by VTD with daratumumab consolidation |
| Randomization 2: daratumumab as single agent in maintenance vs observation only | |||
| NCT02874742 | 2 | NDMM, transplant eligible | RVD + daratumumab induction–high-dose melphalan plus autologous stem cell rescue, followed by RVD plus daratumumab consolidation, followed by daratumumab plus lenalidomide maintenance |
| vs | |||
| RVD induction–high-dose melphalan plus autologous stem cell rescue, followed by RVD consolidation, followed by lenalidomide maintenance | |||
| EMN study | 3 | NDMM, transplant eligible | Randomization 1: KRD induction therapy, followed by high-dose melphalan plus autologous stem cell rescue, followed by KRD consolidation vs KRD with daratumumab induction therapy, followed by high-dose melphalan plus autologous stem cell rescue, followed by KRD with daratumumab consolidation |
| Randomization 2: daratumumab or daratumumab plus lenalidomide maintenance | |||
| NCT02955810 | 1 | NDMM, transplant eligible | CyBorD plus daratumumab induction–high-dose melphalan plus autologous stem cell rescue, followed by CyBorD plus daratumumab consolidation, followed by maintenance with daratumumab (low-risk) or daratumumab plus bortezomib (high-risk) |
| NCT02951819 | 2 | Untreated NDMM and relapsed MM | CyBorD plus daratumumab induction, followed by daratumumab plus dexamethasone maintenance |
| NCT02252172 (Maia) | 3 | NDMM, transplant ineligible | Rd vs DRd |
| NCT02195479 (Alcyone) | 3 | NDMM, transplant ineligible | VMP vs VMP plus daratumumab |
| Hovon143 | 2 | NDMM, transplant ineligible and frail or unfit | Ixazomib-dexamethasone plus daratumumab induction, followed by ixazomib plus daratumumab maintenance |
| NCT03012880 | 2 | NDMM, 18 y and older | Ixazomib-Rd plus daratumumab |
| NCT01998971 | 1b | NDMM, irrespective of transplant eligibility for Vd, VTD, and KRD, and transplant ineligible for VMP | Daratumumab combined with Vd, VTD, KRD, or VMP |
| NCT02513186 | 1 | NDMM, transplant ineligible | Isatuximab plus CyBorD or VRD |
| NCT03104842 | 2 | NDMM, transplant eligible and high-risk cytogenetic abnormalities | Isatuximab plus KRD induction, followed by high-dose melphalan plus autologous stem cell rescue, followed by isatuximab plus KRD consolidation, followed by isatuximab plus KR maintenance |
| NDMM, transplant ineligible and high-risk cytogenetic abnormalities | Isatuximab plus KRD induction followed by isatuximab plus KR maintenance |
| Study . | Phase . | Patients . | Treatment . |
|---|---|---|---|
| NCT02316106 (Centaurus) | 2 | Intermediate or high-risk smoldering MM | 3 dose schedules of daratumumab as single agent (short, intermediate, and long treatment duration) |
| NCT02960555 | 2 | High-risk smoldering MM | Isatuximab as single agent |
| Cassiopeia (IFM 2015-01; HOVON 131; NCT02541383) | 3 | NDMM, transplant eligible | Randomization 1: VTD induction therapy, followed by high-dose melphalan plus autologous stem cell rescue, followed by VTD consolidation vs VTD with daratumumab induction therapy, followed by high-dose melphalan plus autologous stem cell rescue, followed by VTD with daratumumab consolidation |
| Randomization 2: daratumumab as single agent in maintenance vs observation only | |||
| NCT02874742 | 2 | NDMM, transplant eligible | RVD + daratumumab induction–high-dose melphalan plus autologous stem cell rescue, followed by RVD plus daratumumab consolidation, followed by daratumumab plus lenalidomide maintenance |
| vs | |||
| RVD induction–high-dose melphalan plus autologous stem cell rescue, followed by RVD consolidation, followed by lenalidomide maintenance | |||
| EMN study | 3 | NDMM, transplant eligible | Randomization 1: KRD induction therapy, followed by high-dose melphalan plus autologous stem cell rescue, followed by KRD consolidation vs KRD with daratumumab induction therapy, followed by high-dose melphalan plus autologous stem cell rescue, followed by KRD with daratumumab consolidation |
| Randomization 2: daratumumab or daratumumab plus lenalidomide maintenance | |||
| NCT02955810 | 1 | NDMM, transplant eligible | CyBorD plus daratumumab induction–high-dose melphalan plus autologous stem cell rescue, followed by CyBorD plus daratumumab consolidation, followed by maintenance with daratumumab (low-risk) or daratumumab plus bortezomib (high-risk) |
| NCT02951819 | 2 | Untreated NDMM and relapsed MM | CyBorD plus daratumumab induction, followed by daratumumab plus dexamethasone maintenance |
| NCT02252172 (Maia) | 3 | NDMM, transplant ineligible | Rd vs DRd |
| NCT02195479 (Alcyone) | 3 | NDMM, transplant ineligible | VMP vs VMP plus daratumumab |
| Hovon143 | 2 | NDMM, transplant ineligible and frail or unfit | Ixazomib-dexamethasone plus daratumumab induction, followed by ixazomib plus daratumumab maintenance |
| NCT03012880 | 2 | NDMM, 18 y and older | Ixazomib-Rd plus daratumumab |
| NCT01998971 | 1b | NDMM, irrespective of transplant eligibility for Vd, VTD, and KRD, and transplant ineligible for VMP | Daratumumab combined with Vd, VTD, KRD, or VMP |
| NCT02513186 | 1 | NDMM, transplant ineligible | Isatuximab plus CyBorD or VRD |
| NCT03104842 | 2 | NDMM, transplant eligible and high-risk cytogenetic abnormalities | Isatuximab plus KRD induction, followed by high-dose melphalan plus autologous stem cell rescue, followed by isatuximab plus KRD consolidation, followed by isatuximab plus KR maintenance |
| NDMM, transplant ineligible and high-risk cytogenetic abnormalities | Isatuximab plus KRD induction followed by isatuximab plus KR maintenance |
CyBorD, cyclophosphamide-bortezomib-dexamethasone; DRd, daratumumab plus lenalidomide-dexamethasone; KR, carfilzomib and lenalidomide; KRD, carfilzomib-lenalidomide-dexamethasone; NDMM, newly diagnosed MM; Rd, lenalidomide-dexamethasone; Vd, bortezomib-dexamethasone; VMP, bortezomib-melphalan-prednisone; VRD or RVD, bortezomib-lenalidomide-dexamethasone; VTD, bortezomib-thalidomide-dexamethasone.