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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00323518 | A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis | PHASE2 | COMPLETED | 390 | — | — | May 1, 2006 | Aug 1, 2008 | Apr 13, 2016 | 33 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | PLACEBO_COMPARATOR | placebo |
| 2 | EXPERIMENTAL | 30 mcg/kg velafermin |
| 3 | EXPERIMENTAL | 10 mcg/kg velafermin |
| 4 | EXPERIMENTAL | 60 mcg/kg velafermin |
| Name | Type | Description |
|---|---|---|
| velafermin | DRUG | administered intravenously as 100mL single dose over 15 minutes on day 1 |
| placebo | DRUG | administered intravenously as 100mL single dose over 15 minutes on day 1 |
Inclusion Criteria: * Age 18 years or older * Patients with multiple myeloma or lymphoma receiving myeloablative CT with or without TBI that require autologous stem cell support. The CT regimens are limited to high dose melphalan (200 mg/m2) as a single agent, BEAM, or TBI with cyclophosphamide or ...