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IMP phase I/II study in transplant-ineligible NDMM
investigation as MM maintenance therapy following ASCT (TOURMALINE-MM3; clinicaltrials.gov identifier 02181413). A second phase III study is also investigating weekly ixazomib as maintenance therapy after initial induction therapy without ASCT (TOURMALINE-MM4; clinicaltrials.gov identifier 02312258). Phase III investigation of IMP followed by ixazomib maintenance therapy is not currently planned.
In conclusion, this study demonstrates the feasibility, tolerability, and antimyeloma activity of the all-oral IMP induction regimen followed by long-term maintenance with single-agent oral ixazomib in elderly, transplant-ineligible patients with NDMM. Oral dosing, coupled with a favorable safety profile at the RP2D, make ixazomib particularly suitable for long-term continuous therapy and may offer a more convenient, active, and well-tolerated alternative to a parenterally administered PI in this setting.
Acknowledgments
The authors would like to thank all patients and their families, physicians, research nurses, study coordinators, and research staff participating in this study. The authors acknowledge Jane Saunders and Laura Webb of FireKite, an Ashfield company, part of UDG Healthcare plc, for writing assistance during the development of this manuscript, which was funded by Millennium Pharmaceuticals Inc., and complied with Good Publication Practice 3 ethical guidelines (Battisti WP, et al. Ann Intern Med 2015;163:461-4) and Renda Ferrari, PhD, of Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, for editorial support.
Funding
This study was sponsored by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
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