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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00075881 |
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with newly diagnosed high-risk stage III multiple myeloma.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: bortezomib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study Of PS-341 For Patients With High-Risk, Newly Diagnosed Multiple Myeloma |
Study Start Date: | January 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 7 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma meeting the following criteria:
Measurable or evaluable disease meeting at least 1 of the following criteria:
High-risk disease, defined by ≥ 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No concurrent radiotherapy
Surgery
Other
Study Chair: | Angela Dispenzieri, MD | Mayo Clinic |
Study ID Numbers: | CDR0000349450, ECOG-E2A02 |
Study First Received: | January 9, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00075881 History of Changes |
Health Authority: | United States: Federal Government |
stage III multiple myeloma |
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 |