May 12, 2020 saw the early release of results from the phase III IKEMA ( NCT03275285) trial following recommendation from an Independent Data Monitoring Committee. 1 The randomized, open label, multicenter study evaluated the clinical benefit of theanti-CD38 agent, isatuximab, in combination with carfilzomib and dexamethasone vscarfilzomib and dexamethasone alone in patients with relapsed and/or refractory (RR) multiple myeloma (MM; RRMM) following 1‒ 3 prior lines of therapy. 2
In this first planned interim analysis of the IKEMA trial, the addition of isatuximab to the carfilzomib plus dexamethasone regimen was associated with significantly improved progression-free survival (PFS) rates in patients with RRMM when compared to carfilzomib and dexamethasone alone. These data fulfil the primary endpoint for this study and no new safety concerns were observed.
Isatuximab (10 mg/kg) was administered by intravenous (IV) infusion once weekly for 4 weeks, and then biweekly in 28-day cycles in combination with
- carfilzomib (IV, 20/56 mg/m 2) twice weekly the first three weeks of each cycle
- dexamethasone (IV or oral, standard dose) for the entirety of treatment
- Primary endpoint: PFS
- Secondary endpoints: overall response rate, very good partial response or greater, minimal residual disease, complete response rate, overall survival, and safety.
Key exclusion criteria:
- previously treated with carfilzomib
- primary refractory
- free light chain measurable disease only
- Eastern Cooperative Oncology Group (ECOG) performance status > 2