NCT00171925

Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multiple myeloma is a disease of B-lymphocytes producing malignant plasma cells. Malignant plasma cells induce osteolytic lesions, which is characteristic for progression of multiple myeloma. It is the aim of this study to investigate whether zoledronic acid has an influence on the progression of multiple myeloma.

Conditions

• Multiple Myeloma Stage I

Interventions

Type	Name	Description
DRUG	Zoledronic acid	Zoledronic acid administered via normal saline intravenous infusion (over 15 minutes) every 4 weeks. Dosage was according to calculated creatinine clearance: patients with baseline creatinine clearance \> 60 ml/min received 4 mg; for patients with mild to moderate renal impairment, doses were calculated to achieve the same AUC as that achieved in patients with creatinine clearance of 75 ml/min, assuming target AUC of 0.66 (mg\*hr/l).
DIETARY_SUPPLEMENT	Calcium / Vitamin D	Patients on zoledronic acid received 500 mg calcium and 400-500 IU vitamin D combination tablet daily.

Timeline

• Start date: 2000-08-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2005-09-15
• Last updated: 2012-04-11
• Results posted: 2011-04-20

Locations

1 site across 1 country: Germany