Clinical trial · Interventional
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
NCT01464112CI-TRIAL-00042942completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JNJ-2641585 / VELCADE / Dexamethasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 001
- interventionNames
- Drug: JNJ-2641585 / VELCADE / Dexamethasone
Primary outcomes (1)
- measure
- Determine the dose-limiting toxicity and set the MTD for the combination of JNJ-26481585 and VELCADE-dexamethasone
- timeFrame
- Maximum of 18 months
- description
- Based on the safety analysis of all cohorts using the patients-treated population
Secondary outcomes (14)
- measure
- Adverse events
- timeFrame
- Maximum of 18 months
- description
- As a measure of safety
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTMoreau 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 26758913