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Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I

NCT00171925 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2012-04-11

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-08-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00171925 on ClinicalTrials.gov