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Multiple Myeloma Clinical Trials

Ricolinostat (ACY-1215) Clinical Trials

Acetylon is currently sponsoring multiple clinical trials of ricolinostat (ACY-1215). One trial (ACY-100 study) is evaluating ricolinostat when used alone and in combination with Velcade® (bortezomib) and dexamethasone. Another trial (ACE-MM-101 study) is evaluating ricolinostat when used in combination with Revlimid® (lenalidomide) and dexamethasone. The third ongoing study (ACE-MM-102 study) is evaluating ricolinostat when used in combination with Pomalyst® (pomalidomide) and low-dose dexamethasone. The fourth ongoing study (ACE-MM-104) is evaluating a liquid formulation of ricolinostat in combination with Pomalyst (pomalidomide) and low-dose dexamethasone.

ACY-100 study: A Phase I/II, Open-label, Multicenter Study of ACY-1215 Administered Orally as Monotherapy and in Combination with bortezomib and dexamethasone for the Treatment of Relapsed or Relapsed/Refractory Multiple Myeloma

The ACY-100 study is a three-part study conducted at multiple sites across the U.S., and is partially funded by the Leukemia & Lymphoma Society. The study is currently in the Phase 1b portion to determine the maximum tolerated dose of ricolinostat, alone and in combination with Velcade (bortezomib) and dexamethasone. In Phase 2, the efficacy of ricolinostat will be evaluated in combination with Velcade (bortezomib) and dexamethasone. To find out more about this study, including trial locations, please refer to clinicaltrials.gov study NCT01323751.

ACE-MM-101 study: A Phase I, Open-label, Multicenter Study of ACY-1215 in Combination with Lenalidomide and Dexamethasone for the Treatment of Relapsed or Relapsed/Refractory Multiple Myeloma

The ACE-MM-101 study is being conducted at multiple sites across the U.S. This study will assess the maximum tolerated dose of ricolinostat in combination with Revlimid (lenalidomide) and dexamethasone. To find out more about this study, including trial locations, please refer to clinicaltrials.gov study NCT01583283.

ACE-MM-102 study: A Phase Ib/II, Multicenter, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of ACY-1215 (Ricolinostat) in Combination with Pomalidomide and Low-Dose Dexamethasone in Patients with Relapsed-And-Refractory Multiple Myeloma

The ACE-MM-102 Study is being conducted at multiple sites across the U.S. and Canada and additional sites planned in Europe. This study will assess the side effects and determine the best dose of ricolinostat in combination with Pomalyst (pomalidomide) and low-dose dexamethasone in patients with relapsed-and-refractory multiple myeloma. To find out more about this study, including trial locations, please refer to clinicaltrials.gov study NCT01997840.

ACE-MM-104 study: A Phase IB Multicenter, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Antitumor 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

The ACE-MM-104 study will determine the maximum tolerated dose (MTD), if present, and dose schedule of a new formulation of ricolinostat in combination with Pomalyst (pomalidomide) and low-dose dexamethasone in patients with relapsed or relapsed-and-refractory multiple myeloma. To find out more about this study, including trial locations, please refer to clinicaltrials.gov study NCT02189343.

ACY-241 Clinical Trials

ACE-MM-200 study: A Phase 1a/1b Multicenter, Single-Arm, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Preliminary Activity of Oral ACY-241 Alone and in Combination with Pomalidomide and Low-Dose Dexamethasone in Patients with Relapsed or Relapsed-and-Refractory Multiple Myeloma

The ACE-MM-200 study is being conducted at up to 18 sites in the U.S. and Europe. Part A of the study will determine dose-limiting toxicities (DLTs), if present, and resultant maximum tolerated dose (MTD) for oral administration of ACY-241 alone in patients with relapsed or relapsed-and-refractory multiple myeloma. Part B of the study will evaluate DLTs, if present, and MTD to determine the recommended Phase 2 dose and schedule of ACY-241 for oral administration in combination therapy with pomalidomide and low-dose dexamethasone for further clinical investigation. Patients thus will receive ACY-241 alone in the first cycle of treatment (Part A), and then after 4 weeks they receive the ACY-241 in combination with pomalidomide (Pomalyst®, Celgene) and dexamethasone (Part B). To find out more about this study, including trial locations, please refer to clinicaltrials.gov study NCT02400242.