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
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
3 other identifiers
interventional
18
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 multiple-myeloma
Started Sep 2011
Shorter than P25 for phase_1 multiple-myeloma
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2011
CompletedStudy Start
First participant enrolled
September 16, 2011
CompletedFirst Posted
Study publicly available on registry
November 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2013
CompletedJanuary 22, 2020
January 1, 2020
2.2 years
August 30, 2011
January 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the dose-limiting toxicity and set the MTD for the combination of JNJ-26481585 and VELCADE-dexamethasone
Based on the safety analysis of all cohorts using the patients-treated population
Maximum of 18 months
Secondary Outcomes (14)
Adverse events
Maximum of 18 months
Clinical laboratory tests
Maximum of 18 months
Overall response rate
Maximum of 18 months
Duration of response
Maximum of 18 months
Profile of pharmacokinetics evaluations for JNJ-26481585
Maximum of 18 months
- +9 more secondary outcomes
Study Arms (1)
001
EXPERIMENTALInterventions
JNJ-26481585: type=range, unit=mg, number=6 to 12, form=capsules, route=oral use, on Days 1, 3, and 5 of each week. VELCADE: type=exact, unit=mg/m2, number=1.3, form=powder for solution for injection, route=subcutaneous use, on Days 1, 4, 8, and 11 of each 21-day cycle (Cycles 1 to 8) and on Days 1, 8, 15, and 22 of each 35-day cycle (Cycles 9-11). Dexamethasone: type=exact, unit=mg, number=20, form=tablets, route=oral use, on the day of and after VELCADE.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Lille, France
Unknown Facility
Nantes, France
Unknown Facility
Tours, France
Related Publications (1)
Moreau P, Facon T, Touzeau C, Benboubker L, Delain M, Badamo-Dotzis J, Phelps C, Doty C, Smit H, Fourneau N, Forslund A, Hellemans P, Leleu X. Quisinostat, bortezomib, and dexamethasone combination therapy for relapsed multiple myeloma. Leuk Lymphoma. 2016 Jul;57(7):1546-59. doi: 10.3109/10428194.2015.1117611. Epub 2016 Jan 12.
PMID: 26758913RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC & Development, L.L.C. Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2011
First Posted
November 3, 2011
Study Start
September 16, 2011
Primary Completion
November 19, 2013
Study Completion
November 19, 2013
Last Updated
January 22, 2020
Record last verified: 2020-01