Study of ACY-1215 Alone and in Combination With Bortezomib and Dexamethasone in Multiple Myeloma (ACY-1215)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01323751|
Recruitment Status : Completed
First Posted : March 28, 2011
Last Update Posted : April 6, 2017
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: ACY-1215||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2, 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|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 3, 2016|
Experimental: Treat Regimen
ACY-1215 Bortezomib Dexamethasone
Liquid oral dose on Days 1-5 and 8-12 of 21-day treatment cycle
Other Name: HDAC6 inhibitor
- Phase 1 (a & b): To determine the maximum tolerated dose of ACY-1215 as monotherapy or in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. [ Time Frame: Upon completion of 21-day treatment cycle ]
- Phase 2a: To determine the objective response rate to ACY-1215 in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. [ Time Frame: Assessed every other treatment cycle (cycles 2, 4 and 6) ]
- Characterize the safety of ACY-1215 alone or in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma [ Time Frame: Up to 24 weeks ]
- Determine the single- and multiple-dose PK of ACY-1215 alone and in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma [ Time Frame: Upon completion of 21 day treatment cycle ]
- Evaluate the pharmacodynamics of ACY-1215 alone or in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. [ Time Frame: Up to 24 weeks. ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323751
|United States, Georgia|
|Winship Cancer Institute, Emory University|
|Atlanta, Georgia, United States, 30322|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|Mt. Sinai Medical Center|
|New York, New York, United States, 10029|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Wisconsin|
|Medical College of Wisconsin - Clinical Cancer Center|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Sagar Lonial, MD||Winship Cancer Institute, Emory University|
|Other Study ID Numbers:||
|First Posted:||March 28, 2011 Key Record Dates|
|Last Update Posted:||April 6, 2017|
|Last Verified:||April 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Histone Deacetylase Inhibitors
Molecular Mechanisms of Pharmacological Action