Once-weekly vs twice-weekly carfilzomib (K) dosing plus dexamethasone (d) in patients with relapsed and refractory multiple myeloma (RRMM): Results of the randomized phase 3 study A.R.R.O.W.

8000Background: Twice-weekly K at 20/27 mg/m2 is approved for the treatment of RRMM. To develop a more convenient K regimen, once-weekly K plus d was assessed in the phase 1/2 CHAMPION-1 study, establishing a maximum tolerated dose of K 20/70 mg/m2 for RRMM pts. We present results from the pre-planned interim analysis of the phase 3 study A.R.R.O.W. comparing Kd once-weekly at 20/70 mg/m2 (once-weekly group) vs twice-weekly at 20/27 mg/m2 (twice-weekly group). Methods: Pts with 2–3 prior therapies and prior exposure to proteasome inhibitor and immunomodulatory agent were eligible. Pts were randomized 1:1 to receive either once- or twice-weekly K plus d. The once-weekly group received K (30-min IV) on days (D) 1, 8, and 15 of all cycles (20 mg/m2 on D1 [cycle 1]; 70 mg/m2 thereafter). The twice-weekly group received K (10-min IV) on D1, 2, 8, 9, 15, and 16 (20 mg/m2 on D1 and 2 …