Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants
NCT ID: NCT00622505
Last Updated: 2021-05-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
121 participants
INTERVENTIONAL
2007-11-07
2012-04-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Zoledronic acid
Participants received 4 milligrams (mg) or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes, every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine N-telopeptide of type 1 collagen (NTx) measurement (greater than or equal to \[≥\] 50 nanomoles per millimoles \[nmol/mmol\] creatinine or \<50 nmol/mmol creatinine, respectively).
zoledronic acid
Zoledronic acid concentrate (4 mg/5 milliliters \[ml\]) was diluted in 100 mL sterile 0.9% calcium-free sodium chloride or 5% dextrose injection, administered IV, either 4 or 12 weeks for 96 weeks.
Interventions
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zoledronic acid
Zoledronic acid concentrate (4 mg/5 milliliters \[ml\]) was diluted in 100 mL sterile 0.9% calcium-free sodium chloride or 5% dextrose injection, administered IV, either 4 or 12 weeks for 96 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have been on zoledronic acid or pamidronate for 1-2 years and therapy must have been initiated for osteolytic lesion, bone fracture, spinal compression, or osteopenia due to multiple myeloma
* Stable renal function
Exclusion Criteria
* Receiving investigational drugs considered not safe for co-administration or have a significant effect on bone turnover
* Current active dental problems
* Had bone marrow transplant or blood stem cell transplant within 2 months before study entry or planned transplant within 2 months following enrollment
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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TriValley Cancer Research and Treatment Center
Casa Grande, Arizona, United States
Wilshire Oncology Medical Group
La Verne, California, United States
Cedars Sinai Medical Center Outpatient Cancer Ctr. (4)
Los Angeles, California, United States
Palo Alto Medical Foundation Hematology/Oncology
Mountain View, California, United States
Oncology Care Medical Associates
San Gabriel, California, United States
Santa Clara Valley Health & Hospital System
San Jose, California, United States
University of Colorado U of Colorado Cancer Center
Aurora, Colorado, United States
Hematology Oncology PC
Stamford, Connecticut, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Palm Beach Institute of Hematology Oncology
Boynton Beach, Florida, United States
Innovative Medical Research of South Florida Innovative Med Research
Miami Shores, Florida, United States
Cancer Centers of Florida PA Cancer Centers of Central FL
Ocoee, Florida, United States
Integrated Community Oncology Network Florida Oncology Associates
Orange Park, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Loyola University Medical Center /Cardinal Bernardin Cancer Loyola Univ Med Ctr
Maywood, Illinois, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Center for Cancer & Blood Disorders
Bethesda, Maryland, United States
Oncology - Hematology Associates, PA Oncology Hematology Assoc
Clinton, Maryland, United States
Dana Farber Cancer Institute Clinical Research Coordinator
Boston, Massachusetts, United States
Boston VA Healthcare Boston VA
Boston, Massachusetts, United States
Berkshire Hematology Oncology
Pittsfield, Massachusetts, United States
N MS Hematology & Oncology
Tupelo, Mississippi, United States
Hematology & Oncology Consultants, PC Hematology & Oncology
Omaha, Nebraska, United States
Somerset Hematology Oncology Associates Somerset Hema Oncol Assoc (2)
Somerset, New Jersey, United States
Cooper Cancer Center
Voorhees Township, New Jersey, United States
Rochester General Hospital / Lipson Cancer Center Lipson Cancer Center
Rochester, New York, United States
University of Rochester MC / James P. Wilmot Cancer Center James P. Wilmot Cancer Center
Rochester, New York, United States
SUNY - Upstate Medical University Div. of Hematology-Oncology
Syracuse, New York, United States
Carolina Oncology Specialists, PC
Hickory, North Carolina, United States
Regional Hematology-Oncology Associates PC
Langhorne, Pennsylvania, United States
Temple University Temple University
Philadelphia, Pennsylvania, United States
Medical Associates, PA
Charleston, South Carolina, United States
Low Country Hematology Oncology Dept of Lowcountry Hem/Onc
Mt. Pleasant, South Carolina, United States
Lexington Oncology Associates
West Columbia, South Carolina, United States
Avera Research Institute
Sioux Falls, South Dakota, United States
Blood and Cancer Center of East Texas
Tyler, Texas, United States
East Texas Medical Center Cancer Institute
Tyler, Texas, United States
Northern Utah Cancer Associates Dept.ofNorthernUtahAssoc.
Ogden, Utah, United States
Central Utah Clinic Central Utah Clinic (8)
Provo, Utah, United States
Peninsula Cancer Institute
Newport News, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States
West Virginia University Health Research Center Clinical Trial Research Unit
Morgantown, West Virginia, United States
Countries
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References
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Raje N, Vescio R, Montgomery CW, Badros A, Munshi N, Orlowski R, Hadala JT, Warsi G, Argonza-Aviles E, Ericson SG, Anderson KC. Bone Marker-Directed Dosing of Zoledronic Acid for the Prevention of Skeletal Complications in Patients with Multiple Myeloma: Results of the Z-MARK Study. Clin Cancer Res. 2016 Mar 15;22(6):1378-84. doi: 10.1158/1078-0432.CCR-15-1864. Epub 2015 Dec 7.
Other Identifiers
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CZOL446EUS129
Identifier Type: -
Identifier Source: org_study_id
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