Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Washington University School of Medicine |
---|---|
Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00240162 |
The purpose of this study it to evaluate the efficacy of PTK787/ZK 222584, in inducing at least a 50% reduction in paraprotein in patients with multiple myeloma whose paraprotein levels are < 5 g/dL following high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT).
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: PTK787/ZK 222584 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study of PTK787/ZK 222584, a Novel, Oral Angiogenesis Inhibitor as Post Transplant Maintenance Therapy in Patients With Multiple Myeloma Following High Dose Chemotherapy and Autologous Stem Cell Transplant |
Estimated Enrollment: | 50 |
Study Start Date: | September 2005 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
To evaluate the efficacy of PTK787/ZK 222584, in inducing at least a 50% reduction in paraprotein in patients with multiple myeloma whose paraprotein levels are < 5 g/dL following high dose chemotherapy (HDCT) and Autologous Stem Cell Transplantation (ASCT).
To assess the time to progression and disease free survival of patients treated with PTK787/ZK 222584.
To assess the safety and tolerability of PTK787/ZK 222584 in multiple myeloma patients following ASCT.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Washington University School of Medicine. Following HDCT and ASCT patients must have:
Laboratory values less than 2 weeks prior to initiation of treatment:
Exclusion Criteria:
Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
Patients who are taking therapeutic warfarin sodium (Coumadin) or similar oral anticoagulants that are metabolized by the cytochrome P450 system.
Heparin is allowed.
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Ravi Vij, M.D. | Washington University School of Medicine |
Responsible Party: | Washington Universtiy School of Medicine ( Ravi Vij, M.D. ) |
Study ID Numbers: | 05-0639, IND#: 72,721 |
Study First Received: | October 13, 2005 |
Last Updated: | February 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00240162 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Myeloma PTK |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Protein Kinase Inhibitors Angiogenesis Inhibitors Multiple Myeloma Vatalanib Hemorrhagic Disorders Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Blood Protein Disorders Hematologic Diseases Vascular Diseases Enzyme Inhibitors Paraproteinemias Hemostatic Disorders |
Protein Kinase Inhibitors Pharmacologic Actions Vatalanib Multiple Myeloma Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |