Bone Marker Directed Dosing of Zoledronic Acid for the Prevention of Skeletal Complications in Patients With Advanced Multiple Myeloma
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma
Both
Multiple Myeloma
Trial Information
Bone Marker Directed Dosing of Zoledronic Acid for the Prevention of Skeletal Complications in Patients With Advanced Multiple Myeloma
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Proportion of patients with ≥1 SRE at the end of one year on study.
Outcome Time Frame:
1 year
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CZOL446EUS129
NCT ID:
NCT00622505
Start Date:
November 2007
Completion Date:
April 2012
Related Keywords:
- Multiple Myeloma
- Multiple myeloma
- zoledronic acid
- skeletal complications
- bone
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Swedish Cancer Institute | Seattle, Washington 98104 |
| Washington Hospital Center | Washington, District of Columbia 20010 |
| Wilshire Oncology Medical Group | Glendora, California 91741 |
| Avera Research Institute | Sioux Falls, South Dakota 57105 |
| Peninsula Cancer Institute | Newport News, Virginia 23601 |
| Cooper Cancer Center | Voorhees, New Jersey 08043 |
| East Texas Medical Center Cancer Institute | Tyler, Texas 75701 |
| Center for Cancer & Blood Disorders | Bethesda, Maryland 20817 |
| Berkshire Hematology Oncology | Pittsfield, Massachusetts 01201 |
| University of Maryland Greenebaum Cancer Center | Baltimore, Maryland 21201 |
| Blood and Cancer Center of East Texas | Tyler, Texas 75701 |
| Oncology Care Medical Associates | Montebello, California 90640 |
| Hematology Oncology PC | Stamford, Connecticut 06902 |
| Medical Associates, PA | Charleston, South Carolina 29403 |
| Lexington Oncology Associates | West Columbia, South Carolina 29169 |
| Cleveland Clinic Florida | Weston, Florida 33331 |
| Palo Alto Medical Foundation Hematology/Oncology | Mountain View, California 94040 |
| Low Country Hematology Oncology Dept of Lowcountry Hem/Onc | Mt. Pleasant, South Carolina 29464 |
| SUNY - Upstate Medical University Div. of Hematology-Oncology | Syracuse, New York 13210 |
| Dana Farber Cancer Institute Clinical Research Coordinator | Boston, Massachusetts 02115 |
| TriValley Cancer Research and Treatment Center | Casa Grande, Arizona 85222 |
| Cedars Sinai Medical Center Outpatient Cancer Ctr. (4) | Los Angeles, California 90048 |
| Santa Clara Valley Health & Hospital System | San Jose, California 95128 |
| University of Colorado U of Colorado Cancer Center | Aurora, Colorado 80045 |
| Palm Beach Institute of Hematology Oncology | Boynton Beach, Florida 33435 |
| Innovative Medical Research of South Florida Innovative Med Research | Miami Shores, Florida 33138 |
| Cancer Centers of Florida PA Cancer Centers of Central FL | Ocoee, Florida *see dep* |
| Integrated Community Oncology Network Florida Oncology Associates | Orange Park, Florida 32073 |
| Loyola University Medical Center /Cardinal Bernardin Cancer Loyola Univ Med Ctr | Maywood, Illinois 60153 |
| Oncology - Hematology Associates, PA Oncology Hematology Assoc | Clinton, Maryland 20735 |
| Boston VA Healthcare Boston VA | Boston, Massachusetts 02131 |
| N MS Hematology & Oncology | Tupelo, Mississippi 38801 |
| Hematology & Oncology Consultants, PC Hematology & Oncology | Omaha, Nebraska 68122-1799 |
| Somerset Hematology Oncology Associates Somerset Hema Oncol Assoc (2) | Somerset, New Jersey 08873 |
| University of Rochester MC / James P. Wilmot Cancer Center James P. Wilmot Cancer Center | Rochester, New York 14642 |
| Rochester General Hospital / Lipson Cancer Center Lipson Cancer Center | Rochester, New York 14621 |
| Carolina Oncology Specialists, PC | Hickory, North Carolina 28602 |
| Regional Hematology-Oncology Associates PC | Langhorne, Pennsylvania 19047 |
| Temple University Temple University | Philadelphia, Pennsylvania 19140 |
| Northern Utah Cancer Associates Dept.ofNorthernUtahAssoc. | Ogden, Utah 84403-3105 |
| Central Utah Clinic Central Utah Clinic (8) | Provo, Utah 84604 |
| West Virginia University Health Research Center Clinical Trial Research Unit | Morgantown, West Virginia 26506 |
