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:
Novartis Pharmaceuticals
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
Hide Study LocationsLocations
| 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 May 19, 2013