A Multiple Myeloma Trial in Patients With Bone Metastases

Completed · Phase 4

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT00104104

Run by

Novartis Pharmaceuticals

People needed

179

Starts

2004-10-01

Expected to finish

2007-10-01

Last updated by the study team

2011-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Palo Verde Hematology Oncology — Glendale, Arizona, United States
• US Oncology — Tucson, Arizona, United States
• Myeloma Institute For Research Therapy — Little Rock, Arkansas, United States
• University of Arkansas — Little Rock, Arkansas, United States
• Pacific Cancer Medical Center — Anaheim, California, United States
• Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• Southbay Oncology Hematology Partners — Campbell, California, United States
• Bay Area Cancer Research Group — Concord, California, United States
• California Oncology of the Central Valley — Fresno, California, United States
• Dr. Robert P. Brouillard Inc. — La Jolla, California, United States
• Antelope Valley Cancer Center — Lancaster, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• North Valley H/O — Mission Hills, California, United States
• Hematology/Oncology Group of Orange County — Orange, California, United States
• Desert Hematology Oncology Medical Group — Rancho Mirage, California, United States
• Camino Medical Group — Sunnyvale, California, United States
• Oncotherapeutics — West Hollywood, California, United States
• Greeley Medical Center — Greeley, Colorado, United States
• Florida Cancer Specialists — Fort Meyers, Florida, United States
• South Florida Oncology Hematology — Hollywood, Florida, United States
• Osceola Cancer Center — Kissimmee, Florida, United States
• Miami Cancer Care — Miami, Florida, United States
• Pasco Hernado Oncology — New Port Richey, Florida, United States
• MetCare Oncology — Ormond Beach, Florida, United States
• Hematology Oncology Specialists — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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