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news.Japan-based Takeda Pharmaceutical has enrolled the first patient in its Phase III Tourmaline-MM4 trial of investigational oral ixazomib as maintenance therapy for newly diagnosed multiple myeloma (MM).
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The Phase III trial is designed to show whether sustained proteasome inhibition, delivered orally, improves the long term clinical outcomes of people living with MM.
In the trial, the role of ixazomib maintenance therapy will be compared with placebo on the primary endpoint of progression-free survival (PFS) in patients with newly diagnosed multiple myeloma who have responded to initial therapy and have not undergone an autologous stem cell transplant (ASCT).
According to the company, the new trial complements an actively enrolling Phase III maintenance study (TOURMALINE-MM3) in patients who do receive ASCT.
Takeda Oncology Therapeutic Unit global head Michael Vasconcelles said: "We are excited to initiate our second Phase 3 maintenance study which will provide data for patients who do not receive transplant due to age, comorbities or other factors.
"The breadth of our ixazomib development program, which now has a pivotal trial in every major multiple myeloma patient population, demonstrates our commitment to patients battling this disease."
The new trial is the fifth in ixazomib’s Phase III clinical development program, which is evaluating the use of ixazomib in several multiple myeloma settings and in relapsed, refractory systemic light-chain (AL) amyloidosis, a rare but severe plasma cell disorder.