Multiple Myeloma
Conditions
Keywords
Bone Lesions, Multiple Myeloma, zoledronic acid
Brief summary
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.
Interventions
DRUGZoledronic acid
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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/
Outcome results
None listed