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Sponsors and Collaborators: |
Weill Medical College of Cornell University Millennium Pharmaceuticals, Inc. |
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Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00148317 |
PRIMARY STUDY OBJECTIVES
To evaluate the efficacy of the combination of bortezomib, dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as a therapy for two different subsets of multiple myeloma patients:
SECONDARY STUDY OBJECTIVES
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment |
Official Title: | A Sequential Phase II Trial of the Combination of Bortezomib (VELCADE), Dexamethasone (DECADRON) and Pegylated Liposomal Doxorubicin (DOXIL) Followed by High Dose Cyclophosphamide in Multiple Myeloma Patients |
Estimated Enrollment: | 60 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Measurable disease as defined the following:
Exclusion Criteria:
Contact: Ruben Niesvizky, MD | 212-746-3964 |
United States, New York | |
Weill Medical College of Cornell University | Recruiting |
New York, New York, United States, 10021 | |
Contact: Ruben Niesvizky, MD 212-746-3964 | |
Principal Investigator: Ruben Niesvizky, MD |
Principal Investigator: | Ruben Niesvizky, MD | Weill Medical College of Cornell University |
Responsible Party: | Weill Cornell Medical College ( Ruben Niesvizky, MD ) |
Study ID Numbers: | 0504007841 |
Study First Received: | September 2, 2005 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00148317 |
Health Authority: | United States: Institutional Review Board |
Dexamethasone Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias Cyclophosphamide |
Hemostatic Disorders Doxorubicin Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Antibiotics, Antineoplastic Hormones Therapeutic Uses Cardiovascular Diseases Alkylating Agents Neoplasms by Histologic Type Immune System Diseases |
Antineoplastic Agents, Hormonal Gastrointestinal Agents Enzyme Inhibitors Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Protease Inhibitors Neoplasms Autonomic Agents Myeloablative Agonists Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |