Status:
COMPLETED
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
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief 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.
Detailed Description
This is an open-label (patient and study personnel will know what treatment is being administered), multicenter, dose escalation study. Increasing doses of JNJ-26481585 will be explored in combination...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 16 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01464112
Start Date
September 16 2011
End Date
November 19 2013
Last Update
January 22 2020
Active Locations (3)
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1
Lille, France
2
Nantes, France
3
Tours, France