Summary of ongoing trials involving iberdomide or mezigdomide
| NCT number . | Phase . | Study population . | Treatment . | Primary endpoint(s) . |
|---|---|---|---|---|
| NCT04776395 | 2 | Intermediate or high-risk smoldering | IberDex × 4 cycles ⟶ Iber until PD vs Iber until PD | ORR |
| NCT05272826 | 2 | ND TI | IberBorDex | sCR rate after 4 cycles |
| NCT02773030 | 1/2 | ND TI, R/R ND, R/R R/R post-BCMA R/R | DaraIberDex IberBorDex IberDex IberCarDex | MTD, RP2D, ORR |
| NCT05199311 | 1/2 | ND TE | IberCarDex × 2-4 cycles ⟶ ASCT | Rate of TEAEs; CR/sCR rates |
| NCT04934475 (IFM 2020-02) | 3 | ND TE | Isa-KRD induction. Randomization based on MRD status to additional Isa-KRD vs ASCT + IsaKRD consolidation vs tandem ASCT. Maintenance includes randomization to Len × 3 y vs IberIsa × 3 y | MRD negativity rates |
| NCT05177536 | 2 | Post–up-front ASCT | Iber maintenance until PD | 1-y completion rate |
| NCT04564703 | 2 | Post–up-front ASCT | Iber maintenance until PD | Response improvement rate after 6 mo; rate of dose reductions/discontinuations within 6 mo |
| NCT05354557 | 2 | Post–up-front ASCT with ≤VGPR on Len maintenance or post-salvage ASCT after 2-3 prior therapies | Iber maintenance × 12 cycles | 6-mo CR rate |
| NCT04975997 | 3 | R/R with 1-2 prior lines | DaraIberDex vs DaraBorDex | PFS |
| NCT05289492 | 1/2 | R/R with ≥3 prior lines (prior BCMA targeted therapy allowed) | EOS884448, EOS884448-Iber, EOS884448-IberDex | Rate of AEs/SAEs, number of DLTs, RP2D of EOS884448 +/− Iber(Dex), ORR |
| NCT04392037 | 2 | R/R with 2-4 prior lines; Len refractory | IberCyDex | PFS |
| NCT03374085 | 1/2 | R/R with ≥3 prior lines (prior CAR T therapy allowed) | MezigDex | AEs, PK parameters, MTD, ORR |
| NCT03989414 | 1/2 | ND or R/R R/R R/R R/R R/R | MezigBorDex MezigCarDex MezigEloDex MezigIsaDex MezigDaraDex | RP2D, DLTs, AEs, ORR |
| NCT number . | Phase . | Study population . | Treatment . | Primary endpoint(s) . |
|---|---|---|---|---|
| NCT04776395 | 2 | Intermediate or high-risk smoldering | IberDex × 4 cycles ⟶ Iber until PD vs Iber until PD | ORR |
| NCT05272826 | 2 | ND TI | IberBorDex | sCR rate after 4 cycles |
| NCT02773030 | 1/2 | ND TI, R/R ND, R/R R/R post-BCMA R/R | DaraIberDex IberBorDex IberDex IberCarDex | MTD, RP2D, ORR |
| NCT05199311 | 1/2 | ND TE | IberCarDex × 2-4 cycles ⟶ ASCT | Rate of TEAEs; CR/sCR rates |
| NCT04934475 (IFM 2020-02) | 3 | ND TE | Isa-KRD induction. Randomization based on MRD status to additional Isa-KRD vs ASCT + IsaKRD consolidation vs tandem ASCT. Maintenance includes randomization to Len × 3 y vs IberIsa × 3 y | MRD negativity rates |
| NCT05177536 | 2 | Post–up-front ASCT | Iber maintenance until PD | 1-y completion rate |
| NCT04564703 | 2 | Post–up-front ASCT | Iber maintenance until PD | Response improvement rate after 6 mo; rate of dose reductions/discontinuations within 6 mo |
| NCT05354557 | 2 | Post–up-front ASCT with ≤VGPR on Len maintenance or post-salvage ASCT after 2-3 prior therapies | Iber maintenance × 12 cycles | 6-mo CR rate |
| NCT04975997 | 3 | R/R with 1-2 prior lines | DaraIberDex vs DaraBorDex | PFS |
| NCT05289492 | 1/2 | R/R with ≥3 prior lines (prior BCMA targeted therapy allowed) | EOS884448, EOS884448-Iber, EOS884448-IberDex | Rate of AEs/SAEs, number of DLTs, RP2D of EOS884448 +/− Iber(Dex), ORR |
| NCT04392037 | 2 | R/R with 2-4 prior lines; Len refractory | IberCyDex | PFS |
| NCT03374085 | 1/2 | R/R with ≥3 prior lines (prior CAR T therapy allowed) | MezigDex | AEs, PK parameters, MTD, ORR |
| NCT03989414 | 1/2 | ND or R/R R/R R/R R/R R/R | MezigBorDex MezigCarDex MezigEloDex MezigIsaDex MezigDaraDex | RP2D, DLTs, AEs, ORR |
Bor, bortezomib; Car, carfilzomib; CR, complete response; Cy, cyclophosphamide; Dara, daratumumab; Dex, dexamethasone; DLT, dose-limiting toxicity; Elo, elotuzumab; Iber, iberdomide; Isa, isatuximab; KRD, carfilzomib, lenalidomide, dexamethasone; Len, lenalidomide; Mezig, mezigdomide; MRD, minimum residual disease; MTD, maximum tolerated dose; PD, progressive disease; PK, pharmacokinetic; SAE, serious adverse event; sCR, stringent complete response; TE, transplant eligible; TI, transplant ineligible.