Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I

PHASE3TerminatedINTERVENTIONAL
Enrollment

143

Participants

Timeline

Start Date

August 31, 2000

Primary Completion Date

November 30, 2008

Study Completion Date

November 30, 2008

Conditions
Multiple Myeloma Stage I
Interventions
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.

Trial Locations (1)

Unknown

Novartis Investigative Site, Berlin

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY