A Multiple Myeloma Trial in Patients With Bone Metastases

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• Patients 18 years of age or older

• Confirmed diagnosis of Multiple Myeloma

• Stable renal function defined as two serum creatinine determinations of < 3 mg/dL

• Calculated creatinine clearance of greater than or equal to 30 mL/min

• ECOG Performance Status of 0 or 1

• Life expectancy of greater than or equal to 9 months

• If the patient is of child-bearing potential, a negative pregnancy test is required at screening, while postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.

• Ability to comply with trial requirements and give informed consent.

Exclusion Criteria:

• IV Bisphosphonate therapy for more than 3 years.

• Patients with a diagnosis of amyloidosis.

• Known hypersensitivity to zoledronic acid or other bisphosphonates

• Pregnant patients or lactating patients.

• Women of childbearing potential not on a medically recognized form of contraception

• Patients with uncontrolled cardiovascular disease, hypertension, and Type 2 diabetes mellitus.