Study of ACY-1215 Alone and in Combination With Bortezomib and Dexamethasone in Multiple Myeloma

Status: Recruiting
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.

 

Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Noopur Raje, MD, Massachusetts General Hospital

Site-responsible Investigators:

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility 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 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 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 ≥1.5x109/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. Exclusion Criteria - 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)
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