The pharmaceutical company Takeda announced that the Phase 3 TOURMALINE-AL1 clinical trial in patients with relapsed or refractory AL amyloidosis did not meet the first of two primary endpoints.
Treatment with ixazomib in combination with dexamethasone did not demonstrate a significant improvement in overall hematologic response compared to physician’s choice of standard of care regimens. As a result of this analysis, Takeda has decided to discontinue the trial. Read more information here.
About the TOURMALINE-AL1 Trial
TOURMALINE-AL1 (NCT01659658) is an international, randomized, controlled, open-label, multicenter, Phase 3 study, designed to determine whether ixazomib in combination with dexamethasone improves hematologic response, 2-year vital organ (heart or kidney) deterioration and mortality rate versus a physician’s choice of a chemotherapy regimen in participants diagnosed with relapsed or refractory systemic light chain (AL) amyloidosis. Patients were randomly selected to receive either ixazomib plus dexamethasone, or physician’s choice of dexamethasone plus melphalan; dexamethasone plus cyclophosphamide; dexamethasone plus thalidomide; dexamethasone plus lenalidomide; or dexamethasone alone.