Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants
Z-MARK
Bone Marker-directed Dosing of ZOMETA® (Zoledronic Acid) for the Prevention of Skeletal Complications in Patients With Advanced Multiple Myeloma.
1 other identifier
interventional
121
1 country
42
Brief Summary
This study evaluated the effectiveness and safety of a dosing method for zoledronic acid in preventing skeletal complications in multiple myeloma participants who have been on an intravenous (IV) bisphosphonate for about one to two years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 multiple-myeloma
Started Nov 2007
Typical duration for phase_4 multiple-myeloma
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 7, 2007
CompletedFirst Submitted
Initial submission to the registry
February 14, 2008
CompletedFirst Posted
Study publicly available on registry
February 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 3, 2012
CompletedResults Posted
Study results publicly available
May 26, 2021
CompletedMay 26, 2021
May 1, 2021
4.4 years
February 14, 2008
May 3, 2021
May 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With ≥1 SRE at the End of 1 Year on Study
SRE was defined as pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or hypercalcemia of malignancy (HCM). SRE was assessed by centrally read radiographic bone surveys.
1 year
Secondary Outcomes (9)
Time to First SRE on Study
Up to 2 years
Percentage of Participants Who Experienced Pathologic Bone Fracture
Years 1 and 2
Percentage of Participants Who Experienced Spinal Cord Compression
Years 1 and 2
Percentage of Participants Who Experienced Radiation to Bone
Years 1 and 2
Percentage of Participants Who Experienced Surgery to Bone
Years 1 and 2
- +4 more secondary outcomes
Study Arms (1)
Zoledronic acid
EXPERIMENTALParticipants 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).
Interventions
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.
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of multiple myeloma
- 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
You may not qualify if:
- Known sensitivity to bisphosphonates
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
TriValley Cancer Research and Treatment Center
Casa Grande, Arizona, 85222, United States
Wilshire Oncology Medical Group
La Verne, California, 91750, United States
Cedars Sinai Medical Center Outpatient Cancer Ctr. (4)
Los Angeles, California, 90048, United States
Palo Alto Medical Foundation Hematology/Oncology
Mountain View, California, 94040, United States
Oncology Care Medical Associates
San Gabriel, California, 91776, United States
Santa Clara Valley Health & Hospital System
San Jose, California, 95128, United States
University of Colorado U of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Hematology Oncology PC
Stamford, Connecticut, 06902, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Palm Beach Institute of Hematology Oncology
Boynton Beach, Florida, 33435, United States
Innovative Medical Research of South Florida Innovative Med Research
Miami Shores, Florida, 33138, United States
Cancer Centers of Florida PA Cancer Centers of Central FL
Ocoee, Florida, *see dep*, United States
Integrated Community Oncology Network Florida Oncology Associates
Orange Park, Florida, 32073, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Loyola University Medical Center /Cardinal Bernardin Cancer Loyola Univ Med Ctr
Maywood, Illinois, 60153, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Center for Cancer & Blood Disorders
Bethesda, Maryland, 20817, United States
Oncology - Hematology Associates, PA Oncology Hematology Assoc
Clinton, Maryland, 20735, United States
Dana Farber Cancer Institute Clinical Research Coordinator
Boston, Massachusetts, 02115, United States
Boston VA Healthcare Boston VA
Boston, Massachusetts, 02131, United States
Berkshire Hematology Oncology
Pittsfield, Massachusetts, 01201-8298, United States
N MS Hematology & Oncology
Tupelo, Mississippi, 38801, United States
Hematology & Oncology Consultants, PC Hematology & Oncology
Omaha, Nebraska, 68122-1799, United States
Somerset Hematology Oncology Associates Somerset Hema Oncol Assoc (2)
Somerset, New Jersey, 08873, United States
Cooper Cancer Center
Voorhees Township, New Jersey, 08043, United States
Rochester General Hospital / Lipson Cancer Center Lipson Cancer Center
Rochester, New York, 14621, United States
University of Rochester MC / James P. Wilmot Cancer Center James P. Wilmot Cancer Center
Rochester, New York, 14642, United States
SUNY - Upstate Medical University Div. of Hematology-Oncology
Syracuse, New York, 13210, United States
Carolina Oncology Specialists, PC
Hickory, North Carolina, 28602, United States
Regional Hematology-Oncology Associates PC
Langhorne, Pennsylvania, 19047, United States
Temple University Temple University
Philadelphia, Pennsylvania, 19140, United States
Medical Associates, PA
Charleston, South Carolina, 29403, United States
Low Country Hematology Oncology Dept of Lowcountry Hem/Onc
Mt. Pleasant, South Carolina, 29464, United States
Lexington Oncology Associates
West Columbia, South Carolina, 29169, United States
Avera Research Institute
Sioux Falls, South Dakota, 57105, United States
Blood and Cancer Center of East Texas
Tyler, Texas, 75701, United States
East Texas Medical Center Cancer Institute
Tyler, Texas, 75701, United States
Northern Utah Cancer Associates Dept.ofNorthernUtahAssoc.
Ogden, Utah, 84403-3105, United States
Central Utah Clinic Central Utah Clinic (8)
Provo, Utah, 84604, United States
Peninsula Cancer Institute
Newport News, Virginia, 23601, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
West Virginia University Health Research Center Clinical Trial Research Unit
Morgantown, West Virginia, 26506, United States
Related Publications (1)
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.
PMID: 26644410RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2008
First Posted
February 25, 2008
Study Start
November 7, 2007
Primary Completion
April 3, 2012
Study Completion
April 3, 2012
Last Updated
May 26, 2021
Results First Posted
May 26, 2021
Record last verified: 2021-05