@article{Jesús F. San-Miguel_Maria-Asunción Echeveste Gutierrez_Ivan Špicka_María-Victoria Mateos_Kevin Song_Michael D. Craig_Joan Bladé_Roman Hájek_Christine Chen_Alessandra Di Bacco_Jose Estevam_Neeraj Gupta_Catriona Byrne_Vickie Lu_Helgi van de Velde_Sagar Lonial_2018, place={Pavia, Italy}, title={A phase I/II dose-escalation study investigating all-oral ixazomib-melphalan-prednisone induction followed by single-agent ixazomib maintenance in transplant-ineligible newly diagnosed multiple myeloma}, volume={103}, url={https://haematologica.org/article/view/8591}, DOI={10.3324/haematol.2017.185991}, abstractNote={This phase I/II dose-escalation study investigated the all-oral ixazomib-melphalan-prednisone regimen, followed by single-agent ixazomib maintenance, in elderly, transplant-ineligible patients with newly diagnosed multiple myeloma. Primary phase I objectives were to determine the safety and recommended phase II dose of ixazomib-melphalan-prednisone. The primary phase II objective was to determine the complete plus very good partial response rate. In phase I, patients were enrolled to 4 arms investigating weekly or twice-weekly ixazomib (13 28-day cycles or nine 42-day cycles) plus melphalan-prednisone. In phase II, an expansion cohort was enrolled at the recommended phase II ixazomib dose. Of the 61 patients enrolled, 26 received the recommended phase II dose (ixazomib 4.0 mg [days 1, 8, 15] plus melphalan-prednisone 60 mg/m<sup>2</sup> [days 1-4], 28-day cycles). Of the 61 enrolled patients, 36 (13 of 26 in the recommended phase II dose cohort) received single-agent ixazomib maintenance (days 1, 8, 15; 28-day cycles). In phase I, 10/38 patients reported dose-limiting toxicities in cycle 1, including grade 3 and/or 4 neutropenia (n=6) and thrombocytopenia (n=4). Complete plus very good partial response rate was 48% (48% at recommended phase II dose), including 28% (22%) complete response or better; responses deepened during maintenance in 34% (33%) of evaluable patients. After median follow up of 43.6 months, median progression-free survival was 22.1 months. Adverse events were mainly hematologic events, gastrointestinal events, and peripheral neuropathy. This study demonstrates the feasibility, tolerability, and activity of ixazomib-melphalan-prednisone induction and single-agent ixazomib maintenance in transplant-ineligible newly diagnosed multiple myeloma patients. <em><a href="http://clinicaltrials.gov">clinicaltrials.gov</a> identifier 01335685</em&gt;.}, number={9}, journal={Haematologica}, author={Jesús F. San-Miguel and Maria-Asunción Echeveste Gutierrez and Ivan Špicka and María-Victoria Mateos and Kevin Song and Michael D. Craig and Joan Bladé and Roman Hájek and Christine Chen and Alessandra Di Bacco and Jose Estevam and Neeraj Gupta and Catriona Byrne and Vickie Lu and Helgi van de Velde and Sagar Lonial}, year={2018}, month={Aug.}, pages={1518-1526} }