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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01222286 | Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma | PHASE2 | COMPLETED | 30 | — | — | Sep 1, 2010 | Jan 1, 2013 | May 14, 2026 | 5 | United States |
The primary end point is the rate of patients achieving an objective response (defined according to the International Myeloma Working Group uniform response criteria), including minimal response, (as derived from the European Society for Blood and Marrow Transplantation criteria), achieved at any time until end of study and confirmed on two consecutive assessments at 4 weeks interval.
| Arm | Type | Description |
|---|---|---|
| IPH2101 0.2 mg/kg | EXPERIMENTAL | 0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles |
| IPH2101 2 mg/kg | EXPERIMENTAL | 2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles |
| Name | Type | Description |
|---|---|---|
| IPH2101 | DRUG | 0.2 mg/Kg or 2mg/Kg, every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles |
Inclusion Criteria: 1. SMM of any risk level according to a definition derived of the International Myeloma Working Group definition ( Br J Haematol 2003; 121: 749) : Serum M protein ≥ 3 g/dl , AND/OR Bone Marrow plasma cells ≥ 10 % with no evidence of end-organ damage (CRAB) * (C)Absence of hy...