Date: 2015-05-12
Type of information: Recruitment of the first patient
phase: 3
Announcement: recruitment of the first patient
Company: Takeda Pharmaceutical (Japan) Millennium Pharmaceuticals (USA - MA)
Product: ixazomib (MLN9708 - 2,2\'-{2-[(1R)-1-({[(2,5-dichlorobenzoyl)amino]acetyl}amino)-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid)
Action
mechanism: proteasome inhibitor. Ixazomib (MLN9708) is an investigational oral proteasome inhibitor, which is being studied in multiple myeloma (MM), systemic light-chain (AL) amyloidosis and other malignancies. Ixazomib was granted orphan drug designation in multiple myeloma in both the U.S. and Europe in 2011, and for AL amyloidosis in both the U.S. and Europe in 2012. Ixazomib received Breakthrough Therapy status by the FDA for relapsed and/or refractory AL amyloidosis in 2014. It is also the first oral proteasome inhibitor to enter Phase 3 clinical trials. Four global Phase 3 trials are ongoing: TOURMALINE-MM1, investigating ixazomib vs. placebo in combination with lenalidomide and dexamethasone in relapsed and/or refractory MM; TOURMALINE-AL1, investigating ixazomib plus dexamethasone in patients with relapsed or refractory AL amyloidosis; TOURMALINE-MM2, investigating ixazomib vs. placebo in combination with lenalidomide and dexamethasone in patients with newly diagnosed MM; and TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed MM following induction therapy and autologous stem cell transplant.
Disease: patients with newly diagnosed multiple myeloma who have responded to initial therapy and have not undergone an autologous stem cell transplant (ASCT)
Therapeutic area: Cancer - Oncology
Country:
Trial
details: The TOURMALINE-MM4 study is the fifth in ixazomib’s Phase 3 clinical development program, which is evaluating the use of ixazomib in various multiple myeloma settings and in relapsed, refractory systemic light-chain (AL) amyloidosis, a rare but severe plasma cell disorder. This study is an international, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of maintenance ixazomib therapy – compared to placebo – in adult patients with newly diagnosed multiple myeloma. Eligible study participants have responded to initial multiple myeloma therapy and have not undergone ASCT. The study is investigating the effect of ixazomib on the primary endpoint of PFS, or the length of time that participants are free of disease progression or death. Overall survival and safety are secondary endpoints. Five global Phase 3 trials are ongoing: • TOURMALINE-MM1, investigating ixazomib vs. placebo in combination with lenalidomide and dexamethasone in relapsed and/or refractory MM; • TOURMALINE-AL1, investigating ixazomib plus dexamethasone in patients with relapsed or refractory AL amyloidosis; • TOURMALINE-MM2, investigating ixazomib vs. placebo in combination with lenalidomide and dexamethasone in patients with newly diagnosed MM; • TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed MM following induction therapy and autologous stem cell transplant (ASCT); • TOURMALINE-MM4, investigating ixazomib vs. placebo as maintanence therapy in patients with newly diagnosed MM who have not undergone ASCT.
Latest
news: * On May 12, 2015, Takeda Pharmaceutical Company announced that the first patient has been enrolled in the Phase 3 TOURMALINE-MM4 study of investigational oral ixazomib. This is a superiority study designed to demonstrate whether sustained proteasome inhibition, delivered orally, improves the long term clinical outcomes of people living with multiple myeloma. The Phase 3 TOURMALINE-MM-4 study will evaluate the role of ixazomib maintenance therapy 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). This study complements an actively enrolling Phase 3 maintenance study (TOURMALINE-MM3) in patients who do receive ASCT.
