A phase III doseescalation study investigating alloral ixazomibmelphalanprednisone

Sign up to view full document!

A phase I/II dose-escalation study investigating all-oral ixazomib-melphalan-prednisone induction followed by single-agent ixazomib maintenance

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 by 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, and Sagar Lonial haematol Volume 103(9): 1518 -1526 August 31, 2018 © 2018 by Ferrata Storti Foundation

Phase I study design. Jesús F. San-Miguel et al. Haematologica 2018; 103: 15181526 ©

Phase I study design. Jesús F. San-Miguel et al. Haematologica 2018; 103: 15181526 © 2018 by Ferrata Storti Foundation

Patient demographics and disease characteristics at baseline (safety population). Jesús F. San-Miguel et al.

Patient demographics and disease characteristics at baseline (safety population). Jesús F. San-Miguel et al. Haematologica 2018; 103: 15181526 © 2018 by Ferrata Storti Foundation

Ixazomib dose received and primary reason for discontinuation by study arm (safety population). Jesús

Ixazomib dose received and primary reason for discontinuation by study arm (safety population). Jesús F. San-Miguel et al. Haematologica 2018; 103: 15181526 © 2018 by Ferrata Storti Foundation

Response rates after induction and at end of study (response-evaluable population). Jesús F. San-Miguel

Response rates after induction and at end of study (response-evaluable population). Jesús F. San-Miguel et al. Haematologica 2018; 103: 15181526 © 2018 by Ferrata Storti Foundation

Time-to-event outcomes with IMP induction and single-agent ixazomib maintenance. Jesús F. San-Miguel et al.

Time-to-event outcomes with IMP induction and single-agent ixazomib maintenance. Jesús F. San-Miguel et al. Haematologica 2018; 103: 15181526 © 2018 by Ferrata Storti Foundation

Kaplan-Meier analysis of PFS and OS. (A) PFS for the total patient population in

Kaplan-Meier analysis of PFS and OS. (A) PFS for the total patient population in the overall study (induction and maintenance phases) and in patients who went on to receive maintenance, and (B) OS in the overall study, for the total safety population and th. . . Jesús F. San-Miguel et al. Haematologica 2018; 103: 15181526 © 2018 by Ferrata Storti Foundation

Safety profile with IMP induction and single-agent ixazomib maintenance (safety population). Jesús F. San-Miguel et al. Haematologica 2018; 103: 15181526 © 2018 by Ferrata Storti Foundation

Most common (≥ 30% incidence in either population) any-grade and grade ≥ 3 AEs

Most common (≥ 30% incidence in either population) any-grade and grade ≥ 3 AEs (safety population). Jesús F. San-Miguel et al. Haematologica 2018; 103: 15181526 © 2018 by Ferrata Storti Foundation

Slides: 9

Download presentation