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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00722566 | A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma | PHASE3 | COMPLETED | 222 | — | — | Jul 1, 2008 | Sep 1, 2010 | Oct 10, 2011 | 3 | Belgium, France +1 |
Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR. Complete response requires disappearance of monoclonal protein from the blood and urine and \<5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks. Partial Response requires ≥50% reduction in serum m-protein for at least 2 determinations at least 6 weeks apart and if present, reduction in 24-hour urinary light chain excretion by either ≥90% or to \<200 mg
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | VELCADE administered by subcutaneous injection |
| 2 | ACTIVE_COMPARATOR | VELCADE administered by intravenous infusion |
| Name | Type | Description |
|---|---|---|
| VELCADE Administered by subcutaneous injection | DRUG | Patients will receive a 1.3mg/meters(squared)/dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle |
| VELCADE Administered by intravenous infusion | DRUG | Patients will receive a 1.3mg/meters(squared) dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle. |
Inclusion Criteria: 1. Male or female subjects 18 years or older 2. Diagnosis of multiple myeloma 3. Measurable, secretory multiple myeloma defined as serum monoclonal IgG of ≥10 g/L, serum monoclonal IgA or IgE ≥5 g/L, or serum monoclonal IgD ≥0.5g/L; or urine M-protein of ≥200 mg/24 hr 4. Relapse...