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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00253578 |
RATIONALE: Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with relapsed or refractory multiple myeloma.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: sorafenib tosylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of BAY 43-9006 (Sorafenib) (NSC-724772) in Patients With Relapsing or Resistant Multiple Myeloma |
Estimated Enrollment: | 40 |
Study Start Date: | April 2006 |
Estimated Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of active multiple myeloma
Measurable disease, as defined by ≥ 1 of the following criteria:
Relapsed or refractory disease, as defined by 1 of the following criteria:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Radiotherapy
Other
Principal Investigator: | Mohamad A. Hussein, MD | The Cleveland Clinic |
Study ID Numbers: | CDR0000449973, SWOG-S0434 |
Study First Received: | November 11, 2005 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00253578 |
Health Authority: | United States: Food and Drug Administration |
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Sorafenib Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Cardiovascular Diseases Protein Kinase Inhibitors Pharmacologic Actions |