A Dose Escalation Study of the Histone Deacetylase Inhibitor (HDACi) JNJ 26481585 in Combination With VELCADE (Bortezomib) and Dexamethasone for Patients With Relapsed Multiple Myeloma

• Status: Completed
• Trial end date: 2013-11-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and tolerability and to establish the maximum tolerated dose of JNJ-26481585 combined with VELCADE and dexamethasone.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Histone Deacetylase Inhibitors

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance status score 0-2

• Measurable or secretory multiple myeloma

• Relapse or progression of myeloma following prior systemic antineoplastic therapy

• Pretreatment clinical laboratory values meeting protocol-specified criteria

• Left ventricular ejection fraction rate within normal limits

Exclusion Criteria:

• 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