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Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00171925 |
Multiple myeloma is a disease of B-lymphocytes producing malignant plasma cells. Malignant plasma cells induce osteolytic lesions, which is characteristic for progression of multiple myeloma. It is the aim of this study to investigate whether zoledronic acid has an influence on the progression of multiple myeloma.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma Stage I |
Drug: Zoledronic acid |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Evidence of myeloma according to the criteria of the British Columbia Cancer Agency (for the diagnosis, 2 of the 3 criteria must be met):
Exclusion criteria:
A calculated creatinine clearance < 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula:
CrCl= [140-age (years)] x weight (kg) {x 0.85 for female patients} [72 x serum creatinine (mg/dL)]
Other protocol-defined inclusion and exclusion criteria may apply.
Study ID Numbers: | CZOL446 DE01 |
Study First Received: | September 13, 2005 |
Last Updated: | May 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00171925 |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices |
Multiple Myeloma Stage I Zoledronic acid Progression |
Zoledronic acid Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Disease Progression Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Diphosphonates Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Physiological Effects of Drugs |
Bone Density Conservation Agents Cardiovascular Diseases Pharmacologic Actions |