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JNJ-2641585/ VELCADE/ Dexamethasone · 1 trial · 1 indication
Based on the safety analysis of all cohorts using the patients-treated population
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| JNJ-2641585 / VELCADE / Dexamethasone | DRUG | 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. |
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 *...
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JNJ-2641585 is an investigational small molecule being studied in combination with VELCADE (bortezomib) and dexamethasone for patients with relapsed multiple myeloma. The combination was evaluated in a single Phase 1 dose escalation study conducted in France in adults aged 18 years and older.
JNJ-2641585 is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the Phase 1 study of the agent given with VELCADE and dexamethasone in relapsed multiple myeloma.
JNJ-2641585 is in Phase 1 development. The only registered trial of the combination with VELCADE and dexamethasone was a Phase 1 dose escalation study, and it has been completed. JNJ-2641585 is investigational and has not been approved for any indication.
The trial was NCT01464112, titled a dose escalation study of the histone deacetylase inhibitor JNJ 26481585 in combination with VELCADE (bortezomib) and dexamethasone for patients with relapsed multiple myeloma. It was a completed Phase 1 study that enrolled 18 participants in France.
NCT01464112 was an open-label, uncontrolled Phase 1 dose escalation study, so it was neither randomized nor double blinded. It enrolled 18 adults aged 18 years and older with relapsed multiple myeloma, included both sexes, and did not enroll healthy volunteers. The study has been completed.