Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Millennium: The Takeda Oncology Company and Takeda Pharmaceutical Company have begun Phase 3 trial of MLN9708 in patients with relapsed or refractory light chain AL amyloidosis.
Subscribe to our email newsletter
The TOURMALINE-AL1 multi-centre study will assess once-weekly oral MLN9708, a proteasome inhibitor, in combination with dexamethasone.
Millennium chief medical officer Karen Ferrante said, "The MLN9708 amyloidosis trial employs a unique study design, including novel endpoints, developed by Millennium in collaboration with the FDA and the hematology community."
Patients in the treatment arm of the randomised, controlled open-label, study will be given MLN9708 (4.0mg) orally on first, eighth and fifteenth days along with dexamethasone 20mg/day weekly on first, eighth, fifteenth and twenty second days of each 28-day cycle.
Dexamethasone dose will be increased to 40mg/day after 4 weeks, if tolerated by the subjects.
The treatment will be prolonged untill the progressive disease or unacceptable toxicity is observed in the patients.
The comparator arm will administer any one of the 28-day treatment options such as dexamethasone or, dexamethasone plus melphalan or, dexamethasone plus cyclophosphamide or, dexamethasone plus thalidomide or, dexamethasone plus lenalidomide as directed by the physician.
The overall hematologic response rate, including complete response (CR), very good partial response, partial response, and rate of 2-year vital organ deterioration and mortality rate are the co-primary endpoints of the study.
Safety, overall survival, complete hematologic response CR, progression free survival, duration of response and quality of life include secondary endpoints.