Table 2.
Active Trials of Isatuximab in MM.
| Trial ID [References] | Treatment | Phase | Enrollment | Trial Title |
|---|---|---|---|---|
| NCT02960555 [25] | Isatux | II | 61 | Phase II Single Arm Trial of Isatuximab (SAR650984) in Patients with High Risk Smoldering Multiple Myeloma (ICARIA) |
| NCT02812706 [25] | Isatux | I/II | 42 | A Phase I/II Study of Isatuximab (Anti-CD38 mAb) Administered as a Single Agent in Japanese Patients with Relapsed and Refractory Multiple Myeloma (Islands) |
| NCT02514668 [25,31] | Isatux | I | 64 | An Open-label, Dose-escalation and Multi-center Study to Evaluate the Safety, Pharmacokinetics and Efficacy of SAR650984 (Isatuximab) in Patients with Relapsed/Refractory Multiple Myeloma |
| NCT03194867 | Isatux + Cemip | I/II | 105 | Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Efficacy of Isatuximab in Combination with Cemiplimab in Patients with Relapsed/Refractory Multiple Myeloma |
| NCT03275285 | Isatux + Carf + Dex | III | 300 | Randomized, Open Label, Multicenter Study Assessing the Clinical Benefit of Isatuximab Combined with Carfilzomib (Kyprolis®) And Dexamethasone versus Carfilzomib with Dexamethasone in Patients with Relapse and/or Refractory Multiple Myeloma Previously Treated with 1 to 3 Prior Lines (IKEMA) |
| NCT02990338 [25] | Isatux + Pom + Dex | III | 300 | A Phase 3 Randomized, Open-label, Multicenter Study Comparing Isatuximab (SAR650984) in Combination with Pomalidomide and Low-Dose Dexamethasone versus Pomalidomide and Low-Dose Dexamethasone in Patients with Refractory or Relapsed and Refractory Multiple Myeloma (ICARIA-MM) |
| NCT02513186 | Isatux + Len + Bort + Dex + Cp | I | 44 | A Dose Escalation, Safety, Pharmacokinetic, Pharmacodynamic and Preliminary Efficacy Study of SAR650984 (Isatuximab) Administered Intravenously in Combination with Bortezomib—Based Regimens in Adult Patients with Newly Diagnosed Multiple Myeloma Non-Eligible for Transplantation CyBorDSAR) |
| NCT03617731 | Isatux + Bort + Dex + Len | III | 662 | A Randomized Phase III Trial Assessing the Benefit of the Addition of Isatuximab to Lenalidomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients with Newly Diagnosed Multiple Myeloma (GMMG HD7) |
| NCT01749969 [24] | Isatux + Len + Dex | I | 60 | A Phase 1b Study of SAR650984 (Anti-CD38 mAb) in Combination with Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma |
| NCT03104842 | Isatux + Len + Dex + Carf | II | 153 | Clinical Phase II, Multicenter, Open-label Study Evaluating Induction, Consolidation and Maintenance with Isatuximab (SAR650984), Carfilzomib, Lenalidomide and Dexamethasone (I-KRd) in Primary Diagnosed High-risk Multiple Myeloma Patients |
| NCT02283775 [22,23] | Isatux + Pom + Dex | I | 89 | A Phase 1b Study of SAR650984 (Isatuximab) in Combination with Pomalidomide and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma (PomdeSAR) |
| NCT03319667 | Isatux + Bort + Len + Dex | III | 440 | A Phase 3 Randomized, Open-label, Multicenter Study Assessing the Clinical Benefit of Isatuximab (SAR650984) in Combination with Bortezomib (Velcade®), Lenalidomide (Revlimid®) and Dexamethasone versus Bortezomib, Lenalidomide and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Not Eligible for Transplant (IMROZ) |
Bort = bortezomib; Carf = carfilzomib; Cemip = cemiplimab; Cp = cyclophosphamide; Dex = dexamethasone; Isatux = isatuximab; Len = lenalidomide; Pom = pomalidomide.