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
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 with the standard VELCADE/dexamethasone dose. After the maximum
tolerated dose (MTD) is determined, up to 24 patients will be entered in a treatment group
to receive the MTD (and if deemed necessary a lower dose level) to further assess the safety
and activity of this combination. There will be 3 phases in the study: a Screening Phase
(from signing of informed consent until immediately before dosing), an open-label Treatment
Phase (from the first dose of JNJ-26481585 and VELCADE-dexamethasone until the End of
Treatment Visit), and a Posttreatment/Follow-up Phase. Patients who achieve a positive
response to treatment at the end of Cycle 1 will continue to receive JNJ-26481585 and
VELCADE-dexamethasone for a maximum of 11 cycles (eight 3-week treatment cycles, followed by
three 5-week treatment cycles). Patients with progressive disease (PD) or unacceptable
toxicity will be withdrawn from treatment. In the Follow-Up Phase, patients whose disease
has not progressed or who discontinued treatment for reasons other than PD will be assessed
approximately every 6 weeks until PD is recorded or until the start of subsequent therapy.
The study will end when all patients have been assessed with PD, or 12 months after the last
patient is enrolled, whichever is earlier. Patient safety will be monitored. Drug A,
JNJ-26481585, will be taken orally on Days 1, 3, and 5 of each week at doses starting at 6
mg and escalating to 12 mg. Drug B, VELCADE, will be given by subcutaneous injection (under
the skin) at a dose of 1.3 mg/m2 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). Drug C, dexamethasone,
will be taken orally on the day of and after VELCADE at a dose of 20 mg. Dosing may be
adjusted, based on tolerability.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
No
Janssen Research & Development, LLC & Development, L.L.C. Clinical Trial
Study Director
Janssen Research & Development, LLC
United States: Food and Drug Administration
CR018661
NCT01464112
September 2011
March 2013
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