Phase 1b trial of isatuximab, an anti-CD38 monoclonal antibody, in combination with carfilzomib as treatment of relapsed/refractory multiple myeloma.

ABSTRACT:

Background

Isatuximab (Isa), an anti-CD38 monoclonal antibody, and carfilzomib (K), a next-generation proteasome inhibitor (PI), both have potent single-agent activity in relapsed and refractory multiple myeloma (RRMM).

Methods

This phase 1b study evaluated the combination of Isa and K in 33 patients with RRMM. Isa was administered by intravenous infusion in 3 dosing cohorts: dose level 1 (Isa at 10 mg/kg biweekly), dose level 2 (DL2; Isa at 10 mg/kg weekly for 4 doses and then biweekly), and dose level 3 (Isa at 20 mg/kg weekly for 4 doses and then biweekly) and all patients received K (20 mg/m² intravenously for cycle 1, days 1 and 2, and then 27 mg/m² for all subsequent doses). A standard 3+3 dose-escalation design was used, no dose-limiting toxicity

SUBMITTER: Martin TG 

PROVIDER: S-EPMC8252002 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature