Open-label Study, to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Bone Lesions Secondary to Multiple Myeloma.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
- Confirmed Diagnosis of Durie-Salmon Stage III Multiple Myeloma, with the following
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
- Treatment with other investigational drugs within 30 days before inclusion in the
- 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
Other protocol-defined inclusion/exclusion criteria may apply.