Clinical trial · Interventional
Open-label Study, to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Bone Lesions Secondary to Multiple Myeloma.
NCT00242528CI-TRIAL-00017489withdrawnPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.