Acetylon Pharmaceuticals has started treating patients in a three-part Phase 1-2a trial to evaluate ACY-1215 in adult patients suffering from relapsed and relapsed/refractory multiple myeloma.
The Phase 1 dose-ranging study expects to investigate ACY-1215 alone and in conjunction with bortezomib and dexamethasone.
Following identification of optimal combination dosing in Phase 1, the Phase 2a portion of the study will assess rate and duration of cancer response to ACY-1215 in combination with standard of care treatment to achieve proof-of-concept.
The Phase 1a and 1b portions of the trial aims to establish the maximum tolerated dose of ACY-1215 as monotherapy or in combination with bortezomib and dexamethasone, followed by up to five additional sequential cycles of treatment.
However, the Phase 2a portion is intended to establish the objective response rate to ACY-1215 in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma over up to six 21-day cycles.