Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma

Summary

This is a phase 2, multicenter, open-label study in patients with Newly Diagnosed Multiple Myeloma (NDMM) who have not received prior systemic treatment for multiple myeloma (MM) and who are ineligible for high-dose therapy (HDT)-stem cell transplantation (SCT) due to age (ie, ≥ 65 years) or comorbid disease(s) or with Relapsed and/or Refractory Multiple Myeloma (RRMM).

Timeline

Start

2014-03-05

Primary completion

2018-06-29

Completion

2018-06-29

Publications

• Dimopoulos MA, Grosicki S, Jedrzejczak WW, Nahi H, Gruber A, Hansson M, Gupta N, Byrne C, Labotka R, Teng Z, Yang H, Grzasko N, Kumar S. All-oral ixazomib, cyclophosphamide, and dexamethasone for transplant-ineligible patients with newly diagnosed multiple myeloma. Eur J Cancer. 2019 Jan;106:89-98. doi: 10.1016/j.ejca.2018.09.011. Epub 2018 Nov 22.
• Kumar SK, Grzasko N, Delimpasi S, Jedrzejczak WW, Grosicki S, Kyrtsonis MC, Spencer A, Gupta N, Teng Z, Byrne C, Labotka R, Dimopoulos MA. Phase 2 study of all-oral ixazomib, cyclophosphamide and low-dose dexamethasone for relapsed/refractory multiple myeloma. Br J Haematol. 2019 Feb;184(4):536-546. doi: 10.1111/bjh.15679. Epub 2018 Nov 20.

Drugs

Indications