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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00057564 | A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma | PHASE3 | COMPLETED | 470 | — | — | Feb 1, 2003 | Aug 1, 2013 | Sep 11, 2015 | 99 | United States, Australia +14 |
| Arm | Type | Description |
|---|---|---|
| A (Thalidomide & Dexamethasone) | EXPERIMENTAL | Thalidomide 50mg/day + Dexamethasone 40mg |
| B (Dexamethasone and placebo) | PLACEBO_COMPARATOR | Dexamethasone and placebo |
| Name | Type | Description |
|---|---|---|
| A (Thalidomide + Dexamethasone) | DRUG | Thalidomide 50mg/day + Dexamethasone 40mg |
| B (Placebo + Dexamethasone) | DRUG | Placebo + Dexamethasone 40mg |
Inclusion Criteria: * Active Multiple Myeloma Stage II or III Durie Salmon * Measurable levels of myeloma paraprotein in serum (≥1.0g/dL) or urine (≥ 0.2g excreted in a 24-hour collection sample) * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 * Women of child bearing pote...