Table 2.
Selected Clinical Trials of Isatuximab in Multiple Myeloma (MM)
| Trial ID (References) | Treatment | Phase | Enrollment (N) | Trial Title | |||
|---|---|---|---|---|---|---|---|
| NCT04270409 | (Len + Dex) ± Isa | III | 323 | A phase III randomized, open label, multicenter study of isatuximab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone in patients with high-risk smoldering MM | |||
| NCT0299033851,56–59 | (Pom + Dex) ± Isa | III | 307 | A phase III randomized, open-label, multicenter study comparing isatuximab in combination with pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with RRMM ICARIA-MM | |||
| NCT0327528554,60 | (Isa + Carf + Dex) vs (Carf + Dex) | III | 302 | Randomized, open label, multicenter study assessing the clinical benefit of isatuximab combined with carfilzomib and dexamethasone versus carfilzomib with dexamethasone in patients with RRMM previously treated with 1 to 3 prior lines (IKEMA) | |||
| NCT0251466861 | Isa | I | 55 | An open-label, dose-escalation and multi-center study to evaluate the safety, pharmacokinetics and efficacy of isatuximab in patients with RRMM | |||
| NCT0296055562 | Isa | II | 61 | Phase II single arm trial of isatuximab in patients with high risk smoldering MM | |||
| NCT0233285060,63 | Isa + Carf + Dex | I | 89 | A multi-arm phase Ib study of isatuximab in combination with standard carfilzomib, and high-dose weekly carfilzomib and dexamethasone for the treatment of RRMM | |||
| NCT0331966764 | (Len + Bort + Dex) ± Isa | III | 475 | A phase III randomized, open-label, multicenter study assessing the clinical benefit of isatuximab in combination with bortezomib, lenalidomide and dexamethasone versus bortezomib, lenalidomide and dexamethasone in patients with newly diagnosed MM not eligible for transplant (IMROZ) | |||
| NCT0174996965,66 | Isa + Len + Dex | I | 60 | A phase Ib study of isatuximab in combination with lenalidomide and dexamethasone for the treatment of RRMM | |||
| NCT0228377567–70 | Isa + Pom + Dex | I | 89 | A phase Ib study of isatuximab in combination with pomalidomide and dexamethasone for the treatment of RRMM (PomdeSAR) | |||
Abbreviations: Bort, bortezomib; Carf, carfilzomib; Dex, dexamethasone; Isa, isatuximab; Len, lenalidomide; Pom, pomalidomide.