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Sponsored by: |
Janssen-Ortho Inc., Canada |
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Information provided by: | Janssen-Ortho Inc., Canada |
ClinicalTrials.gov Identifier: | NCT00718640 |
The purpose of this study is to evaluate the effectiveness and safety of bortezomib in patients previously treated for multiple myeloma with limited kidney function.
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: bortezomib Drug: Dexmethasone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of VELCADE in Relapsed and/or Refractory Multiple Myeloma Patients With Impaired Renal Function |
Estimated Enrollment: | 50 |
Estimated Study Completion Date: | May 2012 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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001: Experimental |
Drug: bortezomib
1.3mg/m2 once daily on days 1,4,8,11 of eight 21 days cycles
Drug: Dexmethasone
20 mg/day on says 1, 2, 4, 5, 8, 9, 11, 12 of the 21 day cycles
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Limited Kidney function is a condition that can result from high cancer burden on the body and can result in increased toxicity of anti-cancer treatment. The rationale for this open label study is to assess prospectively the safety and efficacy of bortezomib in renal-compromised patients with multiple myeloma. The study hypothesis is that the study drug will be safe and effective in treatment of previously-treated multiple myeloma patients with limited kidney function. The efficacy of bortezomib will be assessed by measuring serum M-protein and urine M-protein (monoclonal paraprotein) levels at the beginning of each treatment cycle before the injection of the study drug. Safety will be assessed by the monitoring of adverse events, physical examinations (including peripheral neurological examinations), vital sign measurements, hematology and serum biochemistry tests from the time the patient signs the informed consent form until the final /early termination visit. Patients will be treated with bortezomib for up to eight 21-day treatment cycles
Patients enrolled in the study will be treated with bortezomib for up to eight 21-day treatment cycles. The patients will receive intravenous injections of bortezomib on Days 1, 4, 8, and 11. The starting dose of bortezomib, which is also the standard dose in myeloma patients, will be 1.3 mg/m2.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email | info1@veritasmedicine.com |
Study Director: | Janssen-Ortho Inc. Clinical Trial | Janssen-Ortho Inc., Canada |
Responsible Party: | Janssen-Ortho Inc., Canada ( Senior Medical Director, Medical Affairs OB Canada ) |
Study ID Numbers: | CR015082, 26866138MMY2052 |
Study First Received: | July 17, 2008 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00718640 |
Health Authority: | United States: Institutional Review Board |
Impaired Renal Function Multiple Myeloma Velcade Bortezomib |
Dexamethasone Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Cardiovascular Diseases Pharmacologic Actions Protease Inhibitors |