Ixazomib maintenance therapy in newly diagnosed multiple myeloma: An integrated analysis of four phase I/II studies

Meletios A. Dimopoulos, Jacob P. Laubach, Maria Asunción Echeveste Gutierrez, Norbert Grzasko, Craig C. Hofmeister, Jesus F. San-Miguel, Shaji Kumar, Richard Labotka, Vickie Lu, Deborah Berg, Catriona Byrne, Zhaoyang Teng, Guohui Liu, Helgi van de Velde, Paul G. Richardson

Research output: Contribution to journalArticle

5 Scopus citations

Abstract

Objectives: To evaluate the safety and efficacy of maintenance therapy with the oral proteasome inhibitor ixazomib in patients with newly diagnosed multiple myeloma (NDMM) not undergoing transplantation. Methods: Data were pooled from four NDMM phase I/II studies; patients received induction therapy with once- or twice-weekly ixazomib plus lenalidomide-dexamethasone (IRd), melphalan-prednisone (IMP), or cyclophosphamide-dexamethasone (ICd), followed by single-agent ixazomib maintenance, given at the last tolerated dose during induction, until disease progression, death, or unacceptable toxicity. Results: A total of 121 patients achieved stable disease or better after induction (weekly IRd, n = 25; twice-weekly IRd, n = 18; weekly or twice-weekly IMP, n = 35; weekly ICd, n = 43) and received ≥ 1 dose of ixazomib maintenance. Grade ≥ 3 drug-related adverse events occurred in 24% of patients during maintenance; each event was reported in ≤2% of patients. Rates of complete response were 22% after induction and 35% after maintenance. A total of 28 patients (23%) improved their response during maintenance. Conclusions: Ixazomib maintenance following ixazomib-based induction is associated with deepening of responses and a positive safety profile with no cumulative toxicity in patients with NDMM not undergoing transplantation, suggesting that ixazomib is feasible for long-term administration. Phase III investigation of ixazomib maintenance is ongoing.

Original languageEnglish (US)
Pages (from-to)494-503
Number of pages10
JournalEuropean Journal of Haematology
Volume102
Issue number6
DOIs
StatePublished - Jun 2019

Keywords

  • clinical trials
  • multiple myeloma

ASJC Scopus subject areas

  • Hematology

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    Dimopoulos, M. A., Laubach, J. P., Echeveste Gutierrez, M. A., Grzasko, N., Hofmeister, C. C., San-Miguel, J. F., Kumar, S., Labotka, R., Lu, V., Berg, D., Byrne, C., Teng, Z., Liu, G., van de Velde, H., & Richardson, P. G. (2019). Ixazomib maintenance therapy in newly diagnosed multiple myeloma: An integrated analysis of four phase I/II studies. European Journal of Haematology, 102(6), 494-503. https://doi.org/10.1111/ejh.13231