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Sponsors and Collaborators: |
Millennium Pharmaceuticals, Inc. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00722566 |
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 |
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Multiple Myeloma |
Drug: VELCADE Administered by subcutaneous injection Drug: VELCADE Administered by intravenous infusion |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | An Open-Label Randomized Study of Subcutaneous and Intravenous VELCADE in Subjects With Previously Treated Multiple Myeloma |
Estimated Enrollment: | 192 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
VELCADE administered by subcutaneous injection
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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
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2: Active Comparator
VELCADE administered by intravenous infusion
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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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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)
Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center | 1-866-835-2233 | medical@mlnm.com |
United States, Florida | |
Pasco Hernando Oncology | Recruiting |
Port Richey, Florida, United States, 34562 | |
Contact: Kumar Kapisthalam, M.D. | |
United States, New Jersey | |
Hackensach University Medical Center | Recruiting |
Hackensach, New Jersey, United States, 07601 | |
Contact: David Siegel, M.D. |
Study Director: | Medical Monitor | Ortho Biotech Oncology Research & Development - Unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development ( Clinical Research Monitor ) |
Study ID Numbers: | 26866138 MMY 3021 |
Study First Received: | July 23, 2008 |
Last Updated: | March 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00722566 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Protease Inhibitors Hemorrhagic Disorders Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Blood Protein Disorders Hematologic Diseases Bortezomib Vascular Diseases Enzyme Inhibitors Paraproteinemias |
Hemostatic Disorders Pharmacologic Actions Protease Inhibitors Multiple Myeloma Neoplasms Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |