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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01464112 |
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Date of registration:
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30/08/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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September 16, 2011 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01464112 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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France
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Contacts
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Name:
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Janssen Research & Development, LLC & Development, L.L.C. Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen Research & Development, LLC |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Myeloma
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Intervention(s)
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Drug: JNJ-2641585 / VELCADE / Dexamethasone
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Primary Outcome(s)
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Determine the dose-limiting toxicity and set the MTD for the combination of JNJ-26481585 and VELCADE-dexamethasone
[Time Frame: Maximum of 18 months]
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Secondary Outcome(s)
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Body surface area
[Time Frame: Maximum of 18 months]
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Body temperature
[Time Frame: Maximum of 18 months]
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Bone cell morphology
[Time Frame: Maximum of 18 months]
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Heart rate
[Time Frame: Maximum of 18 months]
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Profile of pharmacokinetics evaluations for JNJ-26481585
[Time Frame: Maximum of 18 months]
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Profile of pharmacokinetics evaluations for VELCADE
[Time Frame: Maximum of 18 months]
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Adverse events
[Time Frame: Maximum of 18 months]
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Clinical laboratory tests
[Time Frame: Maximum of 18 months]
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Height
[Time Frame: Maximum of 18 months]
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Duration of response
[Time Frame: Maximum of 18 months]
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Weight
[Time Frame: Maximum of 18 months]
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Pulse
[Time Frame: Maximum of 18 months]
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Blood pressure
[Time Frame: Maximum of 18 months]
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Overall response rate
[Time Frame: Maximum of 18 months]
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Secondary ID(s)
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2011-001001-27
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26481585MMY1001
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CR018661
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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