CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 179 enrolled
Drug / intervention
zoledronic aciddrug
Likely dose
Zoledronic acid 4 mg IV in 250 mL of calcium-free solution (0.9% sodium chloride or 5% glucose)AI-extracted
Key inclusion· 5
  • Age ≥18 years
  • Confirmed diagnosis of multiple myeloma
  • Stable renal function: serum creatinine <3 mg/dL (two determinations) and creatinine clearance ≥30 mL/min
  • ECOG performance status 0 or 1
Key exclusion· 5
  • Prior IV bisphosphonate therapy for more than 3 years
  • Diagnosis of amyloidosis
  • Known hypersensitivity to zoledronic acid or other bisphosphonates
  • Pregnant or lactating patients

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00104104
NCT00104104Phase 4Completed

A Multicenter,Open Label, Randomized Trial Evaluating the Duration of Infusion of Zoledronic Acid 4 mg IV in Multiple Myeloma Patients With Bone Metastases

Novartis Pharmaceuticals·interventional·Posted Feb 23, 2005·Updated Jun 29, 2011

In Brief

A Phase 4 clinical trial evaluating zoledronic acid for Multiple Myeloma. Completed, enrolled 179 participants across 68 sites.

Detailed Summary

The purpose of this trial is to study the safety of treating patients with multiple myeloma and at least one bone lesion with zoledronic acid 4mg intravenously (IV) every 3 - 4 weeks for 2 years. Patients will receive a zoledronic acid infusion for 15 minutes or 30 minutes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 23, 2005
Enrollment StartOct 1, 2004
Primary CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 21.4 years ago

Interventions

zoledronic aciddrug

4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously.