A Multiple Myeloma Trial in Patients With Bone Metastases
NCT ID: NCT00104104
Last Updated: 2011-06-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
179 participants
INTERVENTIONAL
2004-10-31
2007-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants
NCT00622505
Open-label Study, to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Bone Lesions Secondary to Multiple Myeloma.
NCT00242528
Efficacy and Safety of Zoledronic Acid in Patients With Bone Metastases of Any Solid Tumors or Multiple Myeloma
NCT00219258
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.
NCT00330759
Zoledronic Acid in the Management of Patients With Asymptomatic/Early Stage Multiple Myeloma
NCT00216151
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
zoledronic acid
4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously.
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.
zoledronic acid
4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Novartis Pharmaceuticals
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_CHAIR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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 Associates PA
Pensacola, Florida, United States
Hem/Onc Associates of Central Brevard
Rockledge, Florida, United States
Augusta Oncology Associates
Augusta, Georgia, United States
Georgia Cancer Specialists
Tucker, Georgia, United States
Cancer Care Center
New Albany, Indiana, United States
Hutchinson Clinic, PA
Hutchinson, Kansas, United States
Hematology and Oncology Specialists
New Orleans, Louisiana, United States
Maine Center for Cancer Medicine - Blood Disorders
Scarborough, Maine, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Oncology Hematology Associates, PA
Clinton, Maryland, United States
Maryland Oncology-Hematology PA
Columbia, Maryland, United States
Hematology Oncology Associates of Ohio & Michigan
Lambertville, Michigan, United States
Providence Cancer Center, Clinical Trials Dept
Southfield, Michigan, United States
Kansas City Cancer Center
Kansas City, Missouri, United States
St. Joseph Oncology, Inc.
Saint Joseph, Missouri, United States
The Center for Cancer Care and Research
St Louis, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Nevada Cancer Center
Las Vegas, Nevada, United States
Center for Cancer & Hematology Disease
Cherry Hill, New Jersey, United States
Central Jersey Oncology Center
East Brunswick, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
CINJ at Cooper University Hospital
Voorhees Township, New Jersey, United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States
Hematology Oncology of Western Suffolk
Bay Shore, New York, United States
New York Presbyterian Hospital
New York, New York, United States
Syracuse Hematology/Oncology PC
Syracuse, New York, United States
Dayton Oncology & Hematology, PA
Kettering, Ohio, United States
University of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, United States
Pennsylvania Oncology Associates
Philadelphia, Pennsylvania, United States
Berks Oncology and Hematology Associates
West Reading, Pennsylvania, United States
Hematology & Oncology Associates of RI
Cranston, Rhode Island, United States
Roger Williams Hospital Medical Center
Providence, Rhode Island, United States
Charleston Hematology Oncology
Charleston, South Carolina, United States
Baptist Regional Cancer Center
Knoxville, Tennessee, United States
Center for Oncology Research & Treatment, PA
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Utah Hematology Oncology
Ogden, Utah, United States
Oncology Hematology Associates of Southwest VA
Salem, Virginia, United States
Western Washington Oncology
Lacey, Washington, United States
Swedish Cancer Institute
Seattle, Washington, United States
Fox Valley Hematology Oncology SC
Appleton, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CZOL446EUS97
Identifier Type: -
Identifier Source: org_study_id
US97
Identifier Type: -
Identifier Source: secondary_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.