Phase 1b Study Evaluating ACY-1215 (Ricolinostat) in Combination With Pomalidomide and Dexamethasone in Relapsed or Relapsed-and-Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT02189343
- Lead Sponsor
- Celgene
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose Escalation Cohort ACY-1215 in combination with pomalidomide and dexamethasone Dose Escalating Cohorts of ACY-1215 in combination with pomalidomide and dexamethasone.
- Primary Outcome Measures
Name Time Method Determine Maximum Tolerated Dose (MTD) if any, and recommended dose schedule Every 56 days on treatment, estimated average of 4 months. Identify the MTD of ACY-1215 administered in an alternative liquid formulation (ALF) if present, and identify a recommended dose and schedule. Patients will be followed for completion of 6 28-day Cycles of Study Treatment (for ITT Population analysis).
- Secondary Outcome Measures
Name Time Method Anti-Tumor Activity Upon completion of a 28-day treatment cycle and for the duration of treatment, an estimated average of 4 months. Anti-tumor activity will be measured by objective response to treatment as assessed by the site Investigators using International Myeloma Working Group (IMWG) Uniform Response criteria. Anti-tumor activity will also be measured by duration of response, time to response, and time to progression. The Response rate will be the percentage of patients who achieve PR or better. The number of patients who have at least MR or better will also be collected as clinical benefit response. Progression-free survival (PFS) will be defined as the time from first dose of study treatment to the first documentation of disease progression or death from any cause during the study. For responders, time to tumor response and response duration will be analyzed.
Pharmacokinetics Up to 8 days post first dose Plasma levels of ACY-1215 will be measured to assess the single and multiple dose PK of AC-1215 in combination with pomalidomide and low-dose dexamethasone. Plasma levels of pomalidomide will be measured to assess the PK of pomalidomide in combination with ACY-1215 and low-dose dexamethasone.
Pharmacodynamics Up to 24 hours post first dose Exposure response of ACY-1215 in combination with pomalidomide and low-dose dexamethasone, including biomarkers relating to intracellular protein acetylation, protein levels, mRNA and microRA expression profiles.
Safety Upon completion of a 28-day treatment cycle and for the duration of treatment, an estimated average of 4 months. To assess the type, frequency, and severity of adverse events (AEs) and relationship of AEs to study drug.
Trial Locations
- Locations (3)
UT Southwestern Medical Center Simmons Comprehensive Cancer Center
🇺🇸Dallas, Texas, United States
CTRC at The UT Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
University of Utah Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
UT Southwestern Medical Center Simmons Comprehensive Cancer Center🇺🇸Dallas, Texas, United States