Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01464112 | 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 | PHASE1 | COMPLETED | 18 | — | — | Sep 16, 2011 | Nov 19, 2013 | Jan 22, 2020 | 3 | France |
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 *...