A Multiple Myeloma Trial in Patients With Bone Metastases

June 27, 2011 updated by: Novartis Pharmaceuticals

A Multicenter,Open Label, Randomized Trial Evaluating the Duration of Infusion of Zoledronic Acid 4 mg IV in Multiple Myeloma Patients With Bone Metastases

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Hematology Oncology Specialists
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Palo Verde Hematology Oncology
      • Tucson, Arizona, United States, 85710
        • US Oncology
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Myeloma Institute For Research Therapy
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood and Cancer Center
      • Campbell, California, United States, 95008
        • Southbay Oncology Hematology Partners
      • Concord, California, United States, 94520
        • Bay Area Cancer Research Group
      • Fresno, California, United States, 93710
        • California Oncology of the Central Valley
      • LaJolla, California, United States, 92037
        • Dr. Robert P. Brouillard Inc.
      • Lancaster, California, United States, 93534
        • Antelope Valley Cancer Center
      • Long Beach, California, United States, 90813
        • Pacific Shores Medical Group
      • Mission Hills, California, United States, 91345
        • North Valley H/O
      • Orange, California, United States, 92868
        • Hematology/Oncology Group of Orange County
      • Rancho Mirage, California, United States, 92270
        • Desert Hematology Oncology Medical Group
      • Sunnyvale, California, United States, 94086
        • Camino Medical Group
      • West Hollywood, California, United States, 90069
        • Oncotherapeutics
    • Colorado
      • Greeley, Colorado, United States, 80631
        • Greeley Medical Center
    • Florida
      • Fort Meyers, Florida, United States, 33901
        • Florida Cancer Specialists
      • Hollywood, Florida, United States, 33021
        • South Florida Oncology Hematology
      • Kissimmee, Florida, United States, 34741
        • Osceola Cancer Center
      • Miami, Florida, United States, 33133
        • Miami Cancer Care
      • New Port Richey, Florida, United States, 34652
        • Pasco Hernado Oncology
      • Ormond Beach, Florida, United States, 32174
        • Metcare Oncology
      • Pensacola, Florida, United States, 32501
        • Hematology Oncology Associates PA
      • Rockledge, Florida, United States, 32955
        • Hem/Onc Associates of Central Brevard
    • Georgia
      • Augusta, Georgia, United States, 30901
        • Augusta Oncology Associates
      • Tucker, Georgia, United States, 30084
        • Georgia Cancer Specialists
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Cancer Care Center
    • Kansas
      • Hutchinson, Kansas, United States, 67502
        • Hutchinson Clinic, Pa
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Hematology and Oncology Specialists
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Center for Cancer Medicine - Blood Disorders
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders
      • Clinton, Maryland, United States, 20735
        • Oncology Hematology Associates, PA
      • Columbia, Maryland, United States, 21044
        • Maryland Oncology-Hematology PA
    • Michigan
      • Lambertville, Michigan, United States, 48144
        • Hematology Oncology Associates of Ohio & Michigan
      • Southfield, Michigan, United States, 48075
        • Providence Cancer Center, Clinical Trials Dept
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Kansas City Cancer Center
      • St. Joseph, Missouri, United States, 64507
        • St. Joseph Oncology, Inc.
      • St. Louis, Missouri, United States, 63141
        • The Center for Cancer Care and Research
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89128
        • Nevada Cancer Center
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • Center for Cancer & Hematology Disease
      • East Brunswick, New Jersey, United States, 08816
        • Central Jersey Oncology Center
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Voorhees, New Jersey, United States, 08043
        • CINJ at Cooper University Hospital
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • New Mexico Cancer Care Associates
    • New York
      • Bay Shore, New York, United States, 11706
        • Hematology Oncology of Western Suffolk
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital
      • Syracuse, New York, United States, 13210
        • Syracuse Hematology/Oncology PC
    • Ohio
      • Kettering, Ohio, United States, 45409
        • Dayton Oncology & Hematology, PA
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania, Philadelphia
      • Philadelphia, Pennsylvania, United States, 19106
        • Pennsylvania Oncology Associates
      • West Reading, Pennsylvania, United States, 19611
        • Berks Oncology and Hematology Associates
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • Hematology & Oncology Associates of RI
      • Providence, Rhode Island, United States, 02908
        • Roger Williams Hospital Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Hematology Oncology
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Baptist Regional Cancer Center
    • Texas
      • Dallas, Texas, United States, 75230
        • Center for Oncology Research & Treatment, PA
      • Dallas, Texas, United States, 75390-9179
        • UT Southwestern Medical Center
      • Lubbock, Texas, United States, 79410
        • Joe Arrington Cancer Research and Treatment Center
    • Utah
      • Ogden, Utah, United States, 84403
        • Utah Hematology Oncology
    • Virginia
      • Salem, Virginia, United States, 24153
        • Oncology Hematology Associates of Southwest VA
    • Washington
      • Lacey, Washington, United States, 98503
        • Western Washington Oncology
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
    • Wisconsin
      • Appleton, Wisconsin, United States, 54915
        • Fox Valley Hematology Oncology SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 15 Minute Infusion
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
Drug: zoledronic acid
4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously.
Other Names:
  • ZOMETA®
Experimental: 30 Minute Infusion
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.
Drug: zoledronic acid
4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously.
Other Names:
  • ZOMETA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months
Time Frame: 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.
Baseline and 12 Months
The Number of Participants With Disease Progression
Time Frame: 24 Months
24 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months
Time Frame: 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.
Baseline and 24 Months
Time to First Significant Increase in Serum Creatinine
Time Frame: Up to 24 months
Median time to event in participants who had a clinically relevant increase in serum creatinine.
Up to 24 months
Zoledronic Acid Concentrations
Time Frame: 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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

February 22, 2005

First Submitted That Met QC Criteria

February 22, 2005

First Posted (Estimate)

February 23, 2005

Study Record Updates

Last Update Posted (Estimate)

June 29, 2011

Last Update Submitted That Met QC Criteria

June 27, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446EUS97
  • US97

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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