Study of ACY-1215 Alone and in Combination With Bortezomib and Dexamethasone in Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ACY-1215
Type: Drug
Overall Status
Recruiting
Summary
Phase 1(a & b): To evaluate the side effects and determine the best dose of oral ACY-1215 as monotherapy, and also in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.

Phase 2a: To determine the objective response rate of oral ACY-1215 in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patient has relapsed or relapsed/refractory MM with measurable disease parameters according to the International Myeloma Working Group (IMWG) Criteria

- Refractory is defined as experiencing less than minimal response (MR) to or progressive disease (PD) within 60 days after completion of the most recent anti-MM regimen

- Relapsed is defined as experiencing PD that requires therapy but which is not refractory following the achievement of stable disease (SD) or better to the most recent anti-MM regimen.

- Patient received at least 2 prior regimens for MM.

- Patient received prior treatment for MM with a proteasome inhibitor and an immunomodulatory drug, unless not a candidate for a proteasome inhibitor or an immunomodulatory drug.

- Patient either is not a candidate for autologous stem cell transplant (ASCT), has declined the option of ASCT, or has relapsed after prior ASCT.

- Patient is ≥18 years of age.

- Patient has a Karnofsky Performance Status score of ≥70

- Patient has adequate bone marrow reserve, as evidenced by:

- Absolute neutrophil count (ANC) of ≥1.0x109/L.

- Platelet count of ≥ 75x109/L in patients in whom <50% of bone marrow nucleated cells are plasma cells and ≥50x109/L in patients in whom more than 50% of bone marrow nucleated cells are plasma cells.

- Patient has adequate renal function (calculated creatinine clearance of ≥30 mL/min according to the Cockroft-Gault)

- Patient has adequate hepatic function (serum bilirubin values <2.0 mg/dL and ALT and/or AST values <3 × the upper limit of normal ULN).

- Patient has a corrected serum calcium ≤ULN.

Exclusion Criteria

- Patient has received any of the following therapies:

- Radiotherapy or systemic therapy within 2 weeks of baseline

- Prior peripheral autologous stem cell transplant within 12 wks of Baseline.

- Prior allogeneic stem cell transplant.

- Prior treatment with an HDAC inhibitor.

- Patient has an active systemic infection requiring treatment.

- Patient has a history of other malignancies unless has undergone definitive treatment more than 5 yrs prior to study and without evidence of recurrent malignant disease (excluding basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current prostate-specific antigen <0.1 ng/mL; or cervical intraepithelial neoplasia).

- Patient has known or suspected HIV, positive for hepatitis B or is known or suspected to have active hepatitis C infection.

- Patient has a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness including recent myocardial infarction (within 6 months)or stroke; hypertension requiring >2 medications for adequate control; diabetes mellitus with >2 episodes of ketoacidosis in the preceding 12 months; or chronic obstructive pulmonary disease (COPD) requiring >2 hospitalizations in the preceding 12 months.

- Patient has a QTcF value of >480 msec; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy; previous history of drug-induced QTc prolongation

- Patient has > Grade 2 painful neuropathy or peripheral neuropathy

- Patient has a history of allergic reaction attributable to bortezomib or other compounds containing boron or mannitol (Phase 1b and 2a only)
Locations
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Status: Recruiting
Contact: Jennifer Schreiber Merriweather, RN - 404-778-5920 - jennifer.schreiber@emoryhealthcare.org
Massachusetts General Hospital
Boston, Massachusetts, United States
Status: Recruiting
Contact: Chi La - 617-724-5251 - cla@partners.org
Mt. Sinai Medical Center
New York, New York, United States
Status: Recruiting
Contact: Kenneth Lau - 212-241-7846 - kenneth.lau@mssm.edu
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Kristy Walsh - 215-615-4822 - kristy.walsh@uphs.upenn.edu
MD Anderson Cancer Center
Houston, Texas, United States
Status: Active, not recruiting
Medical College of Wisconsin - Clinical Cancer Center
Milwaukee, Wisconsin, United States
Status: Recruiting
Contact: Paulette Jacobs - 414-805-4594 - pjacobs@mcw.edu
Start Date
July 2011
Sponsors
Acetylon Pharmaceuticals Incorporated
Source
Acetylon Pharmaceuticals Incorporated
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page