A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma
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Purpose
Randomized, open-label, international, multi-center, Phase 3 study in which patients are randomized to receive VELCADE administered by subcutaneous injection or intravenous infusion.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: VELCADE Administered by subcutaneous injection Drug: VELCADE Administered by intravenous infusion |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Randomized Study of Subcutaneous and Intravenous VELCADE in Subjects With Previously Treated Multiple Myeloma |
- Number of Patients With Overall Response (Complete Response + Partial Response) [ Time Frame: Over 4 cycles (prior to the addition of dexamethasone) ] [ Designated as safety issue: No ]
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
- Number of Patients With Complete Response [ Time Frame: Over 4 cycles (prior to the addition of dexamethasone) ] [ Designated as safety issue: No ]
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.
| Enrollment: | 222 |
| Study Start Date: | July 2008 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
VELCADE administered by subcutaneous injection
|
Drug: VELCADE Administered by subcutaneous injection
Patients will receive a 1.3mg/meters(squared)/dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle
|
|
Active Comparator: 2
VELCADE administered by intravenous infusion
|
Drug: VELCADE Administered by intravenous infusion
Patients will receive a 1.3mg/meters(squared) dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female subjects 18 years or older
- Diagnosis of multiple myeloma
- 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
- Relapse or progression of myeloma following prior systemic antineoplastic therapy.
Exclusion Criteria:
- Previous treatment with VELCADE
- More than 3 previous lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a greater than 6 month treatment-free interval)
- Peripheral neuropathy or neuropathic pain of NCI CTCAE Grade ≥2
Any of the following within 3 weeks prior to randomization:
antineoplastic or experimental therapy, corticosteroid use above 10mg a day (prednisone or equivalent), or plasmapheresis
Any of the following within 2 weeks prior to randomization:
radiation therapy, major surgery (kyphoplasty is not considered major surgery)
- Prior malignancy other than multiple myeloma diagnosed or treated within the last 2 years, with the exception of completely resected carcinoma in situ or basal/squamous carcinoma of the skin
Contacts and Locations| Belgium | |
| UZ Brussel Department Medical Oncology Laarbeeklaan 101 | |
| Brussel, Belgium, 1090 | |
| France | |
| Hôtel DIEU, Service D'Hématologie Place Alexis RICORDEAU | |
| NANTES Cedex 01, France, 44093 | |
| Germany | |
| Universitätsklinikum Münster Onkologische Ambulanz West Albert-Schweitzer-Str. 33 | |
| Münster, Germany, 48129 | |
| Study Director: | Medical Monitor | Ortho Biotech Oncology Research & Development - Unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
No publications provided by Millennium Pharmaceuticals, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Millennium Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00722566 History of Changes |
| Other Study ID Numbers: | 26866138 MMY 3021 |
| Study First Received: | July 23, 2008 |
| Results First Received: | August 30, 2011 |
| Last Updated: | October 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013