Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Patients (Z-MARK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00622505
First received: February 14, 2008
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

This study will evaluate the effectiveness and safety of a dosing method for zoledronic acid in preventing skeletal complications in multiple myeloma patients who have been on an IV bisphosphonate for about one to two years.


Condition Intervention Phase
Multiple Myeloma
Drug: zoledronic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Bone Marker Directed Dosing of Zoledronic Acid for the Prevention of Skeletal Complications in Patients With Advanced Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Proportion of patients with ≥1 SRE at the end of one year on study. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to first SRE on study, proportion of each type of SRE, SRE rate, biomarker changes, and survival. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 159
Study Start Date: November 2007
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: zoldronic acid Drug: zoledronic acid
4 mg either 4 or 12 weeks for 96 weeks
Other Name: Zometa

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Known sensitivity to bisphosphonates
  • Receiving investigational drugs considered not safe for co-administration or have 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

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622505

  Hide Study Locations
Locations
United States, Arizona
TriValley Cancer Research and Treatment Center
Casa Grande, Arizona, United States, 85222
United States, California
Wilshire Oncology Medical Group
La Verne, California, United States, 91750
Cedars Sinai Medical Center Outpatient Cancer Ctr. (4)
Los Angeles, California, United States, 90048
Palo Alto Medical Foundation Hematology/Oncology
Mountain View, California, United States, 94040
Oncology Care Medical Associates
San Gabriel, California, United States, 91776
Santa Clara Valley Health & Hospital System
San Jose, California, United States, 95128
United States, Colorado
University of Colorado U of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Connecticut
Hematology Oncology PC
Stamford, Connecticut, United States, 06902
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Palm Beach Institute of Hematology Oncology
Boynton Beach, Florida, United States, 33435
Innovative Medical Research of South Florida Innovative Med Research
Miami Shores, Florida, United States, 33138
Cancer Centers of Florida PA Cancer Centers of Central FL
Ocoee, Florida, United States, *see dep*
Integrated Community Oncology Network Florida Oncology Associates
Orange Park, Florida, United States, 32073
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Illinois
Loyola University Medical Center /Cardinal Bernardin Cancer Loyola Univ Med Ctr
Maywood, Illinois, United States, 60153
United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Center for Cancer & Blood Disorders
Bethesda, Maryland, United States, 20817
Oncology - Hematology Associates, PA Oncology Hematology Assoc
Clinton, Maryland, United States, 20735
United States, Massachusetts
Boston VA Healthcare Boston VA
Boston, Massachusetts, United States, 02131
Dana Farber Cancer Institute Clinical Research Coordinator
Boston, Massachusetts, United States, 02115
Berkshire Hematology Oncology
Pittsfield, Massachusetts, United States, 01201-8298
United States, Mississippi
N MS Hematology & Oncology
Tupelo, Mississippi, United States, 38801
United States, Nebraska
Hematology & Oncology Consultants, PC Hematology & Oncology
Omaha, Nebraska, United States, 68122-1799
United States, New Jersey
Somerset Hematology Oncology Associates Somerset Hema Oncol Assoc (2)
Somerset, New Jersey, United States, 08873
Cooper Cancer Center
Voorhees, New Jersey, United States, 08043
United States, New York
University of Rochester MC / James P. Wilmot Cancer Center James P. Wilmot Cancer Center
Rochester, New York, United States, 14642
Rochester General Hospital / Lipson Cancer Center Lipson Cancer Center
Rochester, New York, United States, 14621
SUNY - Upstate Medical University Div. of Hematology-Oncology
Syracuse, New York, United States, 13210
United States, North Carolina
Carolina Oncology Specialists, PC
Hickory, North Carolina, United States, 28602
United States, Pennsylvania
Regional Hematology-Oncology Associates PC
Langhorne, Pennsylvania, United States, 19047
Temple University Temple University
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Medical Associates, PA
Charleston, South Carolina, United States, 29403
Low Country Hematology Oncology Dept of Lowcountry Hem/Onc
Mt. Pleasant, South Carolina, United States, 29464
Lexington Oncology Associates
West Columbia, South Carolina, United States, 29169
United States, South Dakota
Avera Research Institute
Sioux Falls, South Dakota, United States, 57105
United States, Texas
East Texas Medical Center Cancer Institute
Tyler, Texas, United States, 75701
Blood and Cancer Center of East Texas
Tyler, Texas, United States, 75701
United States, Utah
Northern Utah Cancer Associates Dept.ofNorthernUtahAssoc.
Ogden, Utah, United States, 84403-3105
Central Utah Clinic Central Utah Clinic (8)
Provo, Utah, United States, 84604
United States, Virginia
Peninsula Cancer Institute
Newport News, Virginia, United States, 23601
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
United States, West Virginia
West Virginia University Health Research Center Clinical Trial Research Unit
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00622505     History of Changes
Other Study ID Numbers: CZOL446EUS129
Study First Received: February 14, 2008
Last Updated: February 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Multiple myeloma
zoledronic acid
skeletal complications
bone

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014