Left ventricular ejection fraction rate within normal limits
Peripheral neuropathy or neuralgia >=2, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0
Diagnosis of primary amyloidosis, plasma cell leukemia, or other similar conditions
Diagnosis of Waldenstrom macroglobulinemia with protocol-specified immunoglobulin levels
Prior histone-deacetylase inhibitor therapy - More than 3 prior lines of therapy
Cardiac risk factors: unstable angina or myocardial infarction within the preceding 12 months, congestive heart failure (New York Heart Association Class II-IV), known presence of dilated, hypertrophic, or restrictive cardiomyopathy
Any other cardiac abnormality that, in the opinion of the investigator, medical monitor, or consultant cardiologist, may place the patient at an unacceptably increased risk with study drug
History of any of the following: sustained ventricular tachycardia, ventricular fibrillation, Torsades de Pointes, atrial fibrillation, cardiac arrest, Mobitz II second degree heart block, or third degree heart block - QTc at Screening > 450 ms in males / > 470 ms in females
Family history of short QT syndrome, long QT syndrome
Obligate use of a cardiac pacemaker - Use of medications that may cause Torsades de Pointes
All locations for NCT01464112
Lille Cedex, France
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Tris trial is registered with FDA with number: NCT01464112. The sponsor of the trial is Janssen Research & Development, LLC and it is looking for 18 volunteers for the current phase.
Official trial title: A Phase 1b Dose Escalation Study of the Histone Deacetylase Inhibitor (HDACi) JNJ-26481585 in Combination With VELCADE (Bortezomib) and Dexamethasone for Subjects With Relapsed Multiple Myeloma
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