A Multiple Myeloma Trial in Patients With Bone Metastases

Phase 4

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: zoledronic acid

• Registration Number: NCT00104104
• Lead Sponsor: Novartis Pharmaceuticals

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. Patients will receive a zoledronic acid infusion for 15 minutes or 30 minutes.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-02-22
• Study First Submitted QC: 2005-02-22
• Study First Posted: 2005-02-23
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Results First Submitted: 2011-01-06
• Results First Submitted QC: 2011-05-04
• Status Verified: 2011-06
• Results First Posted: 2011-06-06
• Last Update Submitted: 2011-06-27
• Last Update Posted: 2011-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
15 Minute Infusion	zoledronic acid	Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks
30 Minute Infusion	zoledronic acid	Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.

Primary Outcome Measures

Name	Time	Method
The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months	Baseline and 12 Months	The primary renal safety endpoint was the number of participants with a clinically relevant increase in serum creatinine at 12 months. Serum creatinine was determined prior to each zoledronic acid infusion for all Participants and was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.
The Number of Participants With Disease Progression	24 Months

Secondary Outcome Measures

Name	Time	Method
The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months	Baseline and 24 Months	Serum Creatinine was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.
Time to First Significant Increase in Serum Creatinine	Up to 24 months	Median time to event in participants who had a clinically relevant increase in serum creatinine.
Zoledronic Acid Concentrations	24 months	Samples for drug concentration analysis were drawn at 10 and 15 minutes into the infusion for participants in the 15-minute infusion group and at 25 and 30 minutes into the infusion for patients in the 30-minute infusion group. The mean and median zoledronic acid concentrations were greater in the 15-minute group than in the 30-minute group at both sampling timepoints.

Trial Locations

Locations (68)

Hematology Oncology Specialists; 🇺🇸 Huntsville, Alabama, United States

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

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