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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00525447 | Study of SGN-40, Lenalidomide, and Dexamethasone in Patients With Multiple Myeloma | PHASE1 | COMPLETED | 36 | — | — | Aug 1, 2007 | Feb 1, 2010 | Oct 9, 2014 | 9 | United States |
| NCT00079716 | Study of SGN-40 in Patients With Refractory or Recurrent Multiple Myeloma | PHASE1 | COMPLETED | 44 | — | — | Mar 1, 2004 | Nov 1, 2007 | Dec 18, 2014 | 5 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| SGN-40 | DRUG | 2-12 mg/kg IV (in the vein) on Days 1, 4, 8, 15, and 22 of Cycle 1; 4-12 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 of Cycles 2-4; 4-12 mg/kg IV (in the vein) on Days 1, 8, and 15 of Cycles 5-8. |
| lenalidomide | DRUG | Up to 25 mg daily of a 21-day cycle. |
| dexamethasone | DRUG | 40 mg administered weekly. |
| SGN-40 (anti-huCD40 mAb) | DRUG | 0.5-8 mg/kg IV (in the vein) on Day 1; 0-8 mg/kg on Day 4; 0.5-16 mg/kg on Days 8 and 15; 0-16 mg/kg on Day 29. |
Inclusion Criteria: * Diagnosis of multiple myeloma. * Received at least one prior systemic therapy other than single-agent corticosteroids. * Measurable disease of monoclonal protein greater than or equal to 0.5 gram/dL in plasma or 0.5 gram/24 hr urine collection, or greater than 10 mg/dL free li...