Allogeneic Hematopoietic Stem Cell Transplantation With Ixazomib for High Risk Multiple Myeloma (BMT CTN 1302)

Summary

This study is designed to compare progression-free survival (PFS) from randomization among patients randomized on the BMT CTN 1302 protocol, "Multicenter Phase II, Double-blind Placebo Controlled Trial of Maintenance Ixazomib after Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Multiple Myeloma". It is hypothesized that Ixazomib maintenance therapy will result in improved PFS in patients with high-risk multiple myeloma following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) compared to placebo.

Timeline

Start

2015-08

Primary completion

2020-10-01

Completion

2020-10-01

Outcome

Missed primary endpoint

registry analysis (superiority test); Ixazomib Maintenance vs Placebo; p = 1.0; Log Rank; NCT02440464 ↗

paper At 21 months postrandomization, the ixazomib and placebo groups had similar PFS (55.3% versus 59.1%; P = 1.00) PMID 35840087 ↗

Publications

• Results Bashir Q, Nishihori T, Pasquini MC, Martens MJ, Wu J, Alsina M, Anasetti C, Brunstein C, Dawson P, Efebera Y, Gasparetto C, Geller N, Giralt S, Hall AC, Koreth J, McCarthy P, Scott E, Stadtmauer EA, Vesole DH, Hari P. A Multicenter Phase II, Double-Blind, Placebo-Controlled Trial of Maintenance Ixazomib After Allogeneic Transplantation for High-Risk Multiple Myeloma: Results of the Blood and Marrow Transplant Clinical Trials Network 1302 Trial. Transplant Cell Ther. 2023 Jun;29(6):358.e1-358.e7. doi: 10.1016/j.jtct.2022.07.007. Epub 2022 Jul 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ixazomib	Unknown	4 mg	Oral
Background	Bortezomib	Small molecule	1.3 mg/m2	Intravenous
Background	Fludarabine	Small molecule	30 mg/m2	Intravenous
Background	Melphalan	Small molecule	70 mg/m2	Intravenous

Indications