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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00242528 |
To evaluate the safety and tolerability of intravenous zoledronic acid in the treatment of patients with multiple myeloma stage III with bone lesions related to Cancer.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: Zoledronic acid |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open-Label Study, to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Bone Lesions Secondary to Multiple Myeloma. |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A. At least 1 osteolytic bone lesion demonstrable in a conventional X-ray film. B. The patient will have to be receiving treatment for primary neoplasia, at the time of the start of this trial.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Study ID Numbers: | CZOL446EMX03 |
Study First Received: | October 9, 2005 |
Last Updated: | August 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00242528 History of Changes |
Health Authority: | Mexico: Ethics Committee |
Bone Lesions Multiple Myeloma zoledronic acid |
Immunoproliferative Disorders Zoledronic acid Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Bone Density Conservation Agents Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Diphosphonates Hemorrhagic Disorders Neoplasm Metastasis Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Zoledronic acid Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Blood Protein Disorders Hematologic Diseases Physiological Effects of Drugs Vascular Diseases Bone Density Conservation Agents Paraproteinemias |
Hemostatic Disorders Pharmacologic Actions Multiple Myeloma Neoplasms Diphosphonates Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |