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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01233895 | Study of AVE1642 Anti-IGF1R Monoclonal Antibody in Patients With Advanced Multiple Myeloma | PHASE1 | COMPLETED | 26 | — | — | Sep 1, 2006 | Sep 1, 2008 | Nov 3, 2010 | 4 | France, Italy |
Selected Dose will be based on the AVE1642 clearance /IGF-1 plateaus and on safety (less than 33% of pts with dose limiting toxicity (DLT)when administered as single agent in a first part of the study. The safety and pharmacokinetics of the regimen in combination with bortezomib will be assessed in the second part of the study
| Arm | Type | Description |
|---|---|---|
| AVE1642/ AVE1642 with Velcade | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AVE1642 | DRUG | For Part 1, AVE1642 was administered on Day 1 and then every three weeks intra-venously with the dose escalation step starting at 3 mg/kg/infusion with a classical dose escalation schema of 3+3. For Part 2, AVE1642 was administered at doses ranging from 0.5 mg/kg to 12 mg/kg |
| Velcade | DRUG | For Part 2 ONLY, fixed dose of 1.3 mg/m² administered on Days 1, 4, 8, and 11. |
Inclusion Criteria: * Multiple myeloma confirmed by bone marrow aspirate or biopsy * Patient had to have relapsed and/or refractory multiple myeloma after at least 1 standard therapy, and have demonstrated disease progression * Previous exposure to Velcade was allowed, provided no DLTs of Grade 3 o...