Millennium: The Takeda Oncology Company and the Takeda Pharmaceutical Company have commenced a Phase III trial evaluating MLN9708 in patients with relapsed or refractory light chain AL amyloidosis.
The multi-centre study is designed to assess once-weekly oral MLN9708, a proteasome inhibitor, in combination with dexamethasone.
Millennium chief medical officer Dr 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 the first, eighth and fifteenth day, along with dexamethasone 20mg/day weekly on the first, eighth, fifteenth and twenty second day of each 28-day cycle.
The dexamethasone dose is expected to be increased to 40mg/day after four weeks, if tolerated by the subjects.
The treatment will be continued until the progressive disease or unacceptable toxicity is observed in the patients.
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The comparator arm will administer any one of the 28-day treatment options: dexamethasone, dexamethasone plus melphalan, dexamethasone plus cyclophosphamide, dexamethasone plus thalidomide ordexamethasone plus lenalidomide.
The overall hematologic response rate, including complete response (CR), very good partial response, partial response and rate of two-year vital organ deterioration and mortality rate are the co-primary endpoints of the study.
Secondary endpoints include safety, overall survival, complete hematologic response CR, progression free survival, duration of response and quality of life.
University of Pavia, Italy, Amyloidosis Research and Treatment Center professor Dr Giampaolo Merlini said there is a significant unmet medical need in the treatment of light chain amyloidosis.
"This innovative study design may allow for earlier identification of clinical benefit for these very sick patients, and may establish a standard for future research in systemic amyloidosis," Merlini said.
Image: Takeda Midosuji Building, the head office of Takeda Pharmaceutical Company, in Chuo-ku, Osaka, Japan. Photo: Courtesy of J o.