Study of Oral Ixazomib in Combination With Melphalan and Prednisone in Participants With Newly Diagnosed Multiple Myeloma

Phase 1/2 Completed 61 enrolled Millennium Pharmaceuticals, Inc.

Parallel-groupOpen-labelTreatment

Summary

The purpose of this phase 1/2, open-label study was to evaluate the effect of oral formulation of Ixazomib when added to standard melphalan and prednisone (MP) treatment. Both phases of the study included participants who had newly diagnosed multiple myeloma and were ineligible for high-dose therapy plus stem cell transplantation because of age (≥65 years of age) or coexisting conditions and for whom standard MP treatment was indicated.

Timeline

Start: 2011-06-27
Primary completion: 2016-12-29
Completion: 2016-12-29

Publications

San-Miguel JF, Echeveste Gutierrez MA, Spicka I, Mateos MV, Song K, Craig MD, Blade J, Hajek R, Chen C, Di Bacco A, Estevam J, Gupta N, Byrne C, Lu V, van de Velde H, Lonial S. 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. Haematologica. 2018 Sep;103(9):1518-1526. doi: 10.3324/haematol.2017.185991. Epub 2018 Jun 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ixazomib	Unknown	3 mg	Oral
Subject	Ixazomib	Unknown	3.7 mg	Oral
Subject	Ixazomib	Unknown	4 mg	Oral
Subject	Ixazomib	Unknown	5.5 mg	Oral
Background	Melphalan	Small molecule	6 mg/m2	Oral
Background	Melphalan	Small molecule	9 mg/m2	Oral
Background	Prednisone	Other / unclassified	60 mg/m2	Oral

Study of Oral Ixazomib in Combination With Melphalan and Prednisone in Participants With Newly Diagnosed Multiple Myeloma

Summary

Timeline

Publications

Drugs

Indications