Study of ACY-1215 Alone and in Combination With Bortezomib and Dexamethasone in Multiple Myeloma
Phase: Phase 1/Phase 2
Diagnosis: Multiple Myeloma
NCT ID: NCT01323751
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-053
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.
Massachusetts General Hospital, Dana-Farber Cancer Institute
Noopur Raje, MD,
Massachusetts General Hospital
Paul Richardson, MD,
Dana-Farber Cancer Institute
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute:
Kathleen Colson, 617-632-6303,
- Patient has relapsed or relapsed/refractory MM with measurable disease parameters
according to the International Myeloma Working Group (IMWG) Criteria
- Refractory is defined as disease progression while on or within 60 days after
completion of the most recent anti-MM regimen
- Relapsed is defined as the development of disease progression following the
achievement of 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
- 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 ≥1.5x109/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 within 2 weeks or systemic therapy within 3 wks 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 peripheral neuropathy of Grade 2 or greater intensity
- Patient has a history of allergic reaction attributable to bortezomib or other
compounds containing boron or mannitol (Phase 1b and 2a only)