Efficacy and safety of carfilzomib-lenalidomide-dexamethasone in newly diagnosed multiple myeloma: pooled analysis of four single-arm studies.

Pooled analyses of four single-arm phase 1 and 2 studies (NCT01816971, NCT02405364, NCT01029054, NCT01402284) investigated the clinical effectiveness of carfilzomib-lenalidomide-dexamethasone (KRd) in newly diagnosed multiple myeloma (NDMM). Patients who did (Cohort 1; <i>n</i> = 122) and did not (Cohort 2; <i>n</i> = 99) undergo autologous stem cell transplant (high-dose melphalan [HDM]-ASCT) were included. Patients received a 28-day cycle of induction KRd. The rate of very good partial response or better, the primary endpoint, was 93% in Cohort 1 and 90% in Cohort 2. Two-year progression-free survival and overall survival rates were 88% and 96% for Cohort 1, and 85% and 97% for Cohort 2. At least 90% of patients in each cohort reported ≥1 grade 3 or 4 treatment-emergent adverse events. Subgroup analyses by age, International Staging System stage, and cytogenetic risk were consistent with the overall population. KRd is an effective and tolerable treatment option for patients with NDMM regardless of HDM-ASCT eligibility.