Open-label Study, to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Bone Lesions Secondary to Multiple Myeloma.
This study has been withdrawn prior to enrollment.
Information provided by:
First received: October 9, 2005
Last updated: November 20, 2009
Last verified: November 2009
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.
Drug: Zoledronic acid
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Open-label Study, to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Bone Lesions Secondary to Multiple Myeloma.
| Study Start Date:
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
- Confirmed Diagnosis of Durie-Salmon Stage III Multiple Myeloma, with the following clinical characteristics:
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.
- Ambulatory patients aged ≥ 18 years.
- Treatment with bisphosphonates in any moment during the last 12 months before visit 1. except for those patients that received only one dosis of bisphosphonates for any indication and when the administration has been 14 days before or older.
- Patients with an absence of a bone lesion clearly related to the primary cancer, and that is detectable in a conventional bone X-ray (simple film).
- Patients with a Serum Calcium level of ≤ 8 g/dl (2.00 mmol/L) or ≥ 12 mg/dL (3.00 mmol/L)
- Treatment with other investigational drugs within 30 days before inclusion in the trial.
- Serum Creatinine levels of > 3 mg/dl (265 umol/L).
- Total Billirubin levels of > 2.5 mg/dl (43 umol/L)
- Patients with a heart condition that has the NYHA criteria for a Grade III and IV functional class
Other protocol-defined inclusion/exclusion criteria may apply.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242528
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 9, 2005
||November 20, 2009
||Mexico: Ethics Committee
Keywords provided by Novartis:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 09, 2014
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs