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Also known as VELCADE Administered by subcutaneous injection
VELCADE Administered · 1 trial · 1 indication
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...
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VELCADE Administered by subcutaneous injection is a small molecule therapy being studied in multiple myeloma, a cancer of plasma cells in the bone marrow. It refers to the subcutaneous route of administration of bortezomib, given under the skin rather than intravenously. Takeda Pharmaceutical Company Limited (TAK) is the developer.
VELCADE Administered by subcutaneous injection is used in multiple myeloma, a hematologic cancer affecting plasma cells. The clinical program has evaluated this subcutaneous route in patients with previously treated multiple myeloma. It is an oncology asset developed by Takeda Pharmaceutical Company Limited (TAK).
VELCADE Administered by subcutaneous injection is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor behind the clinical program evaluating this subcutaneous administration route in multiple myeloma patients who had received prior treatment.
VELCADE Administered by subcutaneous injection has been evaluated in Phase 3 clinical development. The Phase 3 study in previously treated multiple myeloma is listed as completed, and no trials for this asset are currently active. It is an investigational route of administration rather than a newly approved product.
The Phase 3 trial for VELCADE Administered by subcutaneous injection is NCT00722566, titled A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma. It enrolled 222 patients across Belgium, France, and Germany, used an active-controlled design, and is now completed.
VELCADE Administered by subcutaneous injection is an alternative name for the subcutaneous route of VELCADE, also known as bortezomib. It describes giving the same small molecule agent under the skin instead of intravenously. The Phase 3 study NCT00722566 compared subcutaneous and intravenous administration in previously treated multiple myeloma.