Status:
COMPLETED
A Multiple Myeloma Trial in Patients With Bone Metastases
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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. Pati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT00104104
Start Date
October 1 2004
End Date
October 1 2007
Last Update
June 29 2011
Active Locations (68)
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1
Hematology Oncology Specialists
Huntsville, Alabama, United States, 35801
2
Palo Verde Hematology Oncology
Glendale, Arizona, United States, 85304
3
US Oncology
Tucson, Arizona, United States, 85710
4
Myeloma Institute For Research Therapy
Little Rock, Arkansas, United States, 72205