Overview

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