High Rate of Sustained Minimal Residual Disease Negativity Predicts Prolonged Survival for the Overall Patient Population in the Phase 2 KRd Plus Autologous Stem Cell Transplantation MMRC Trial

作者：Andrzej Jakubowiak, Noopur Raje, Ravi Vij, Donna Reece, Jesús G. Berdeja, Leonor A Stephens, Kathryn M. Tinari, Cara A. Rosenbaum, Jagoda Jasielec, Paul G. Richardson, Sandeep Gurbuxani, Jennifer Nam, Erica Severson, Amanda McIver, Brittany Wolfe, Sarah Major, Shaun Rosebeck, Andrew Stefka, David K. Johnson, Dominik Dytfeld, Kent A. Griffith, Agata Turowski, Tyler Hycner, Todd M. Zimmerman · 发表于：Blood · 年份：2017 · DOI：10.1182/blood.v130.suppl_1.4533.4533 · 被引用次数：10 · 研究领域：Multiple Myeloma Research and Treatments、Cancer Treatment and Pharmacology、Cancer therapeutics and mechanisms

Abstract Introduction In a phase 2 study designed to assess efficacy of extended treatment (tx) with KRd (carfilzomib [CFZ], lenalidomide [LEN], and dexamethasone [DEX]) plus autologous stem cell transplantation (ASCT), we reported high rates of deep responses, including high rates of stringent complete response (sCR) and minimum residual disease (MRD) negativity in newly diagnosed multiple myeloma (NDMM) patients (pts) after a median of 18 cycles (C) and 25.5 months (mo) of follow-up (f/u). In this analysis, we evaluated the impact of MRD negativity on progression-free survival (PFS). Methods The study enrolled ASCT-eligible pts with NDMM requiring tx per International Myeloma Working Group (IMWG) criteria with no age limitation. Pts received initial four 28-day cycles of KRd induction: CFZ IV 20/36 mg/m2 on days (D) 1, 2, 8, 9, 15, and 16 (20 mg/m2 on D1, 2 of C1 only); LEN PO D1-21 at 25 mg; DEX PO 40 mg/week followed by stem cell collection using G-CSF and plerixafor, melphalan 200 mg/m2, and ASCT. KRd consolidation (C5-8) used the same doses and schedule, except LEN 15 mg in C5 with the option to escalate to prior dose and DEX reduced to 20 mg weekly. After C8, pts received maintenance KRd for an additional 10 cycles using the same doses as in C8, except CFZ on D1, 2, 15, and 16 only. Single-agent LEN was recommended off-study after C18. Primary endpoint was rate of sCR at the end of C8, with MRD among secondary endpoints. Response rates and MRD were evaluated as per cur...