A Study of Ixazomib (NINLARO®) in Combination With Lenalidomide and Dexamethasone (IRD) for the Treatment of Participants With Multiple Myeloma (MM)

Phase 4 Terminated 141 enrolled Takeda

NaSingle-groupOpen-labelTreatment

Summary

The main aim is to evaluate the effect of Ixazomib in combination with lenalidomide and dexamethasone on Multiple Myeloma disease progression at 2 years in participants who previously received a bortezomib-based induction regimen. The study will enroll approximately 160 participants, who are enrolled after completing 3 cycles of chemotherapy (Bortezomib-Based Induction Regimen). They are then treated with Ixazomib in addition to lenalidomide and dexamethasone.

Timeline

Start: 2017-11-13
Primary completion: 2026-03-30
Completion: 2026-03-30

Outcome

Outcome not reported

Stopped: “All participants on the study have concluded treatment, core study activities are complete, and the scientific goals of the study have been met.”

Publications

Rifkin RM, Costello CL, Birhiray RE, Kambhampati S, Richter J, Abonour R, Lee HC, Stokes M, Ren K, Stull DM, Cherepanov D, Bogard K, Noga SJ, Girnius S. In-class transition from bortezomib-based therapy to IRd is an effective approach in newly diagnosed multiple myeloma. Future Oncol. 2024 Jan;20(3):131-143. doi: 10.2217/fon-2023-0272. Epub 2023 Oct 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ixazomib	Unknown	4 mg	Oral
Background	Dexamethasone	Small molecule	40 mg	Oral
Background	Lenalidomide	Other / unclassified	25 mg	Oral