Multiple Myeloma Clinical Trial
Official title:
A Phase 1b Multi-Center, Open Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Anti-Tumor Activity of an Alternative Liquid Formulation of ACY-1215 (Ricolinostat) In Combination With Pomalidomide and Low-Dose Dexamethasone In Patients With Relapsed and Refractory Multiple Myeloma
To determine the maximum tolerated dose (MTD), if present, and dose schedule of ACY-1215 (ricolinostat) in combination with pomalidomide and low-dose dexamethasone in patients with relapsed-and-refractory multiple myeloma.
To determine the maximum tolerated dose (MTD), if present, and to identify a recommended dose
and schedule of ricolinostat administered in an alternative liquid formulation (ALF)
(10mg/mL) in combination with pomalidomide and low-dose dexamethasone in patients with
relapsed or relapsed-and-refractory multiple myeloma.
To evaluate the safety and any anti-tumor activity of ricolinostat administered in
combination with pomalidomide and dexamethasone as treatment for patients with relapsed or
relapsed-and-refractory multiple myeloma, including duration of response.
To assess the Pharmacokinetics and Pharmacodynamics of all three medications administered in
combination, and to assess the Pharmacokinetics of ricolinostat and pomalidomide
specifically. An evaluation of the relationship between response and biomarkers relating to
interacellular acetylation may also be completed.
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