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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
Not Enrolling
Both
Multiple Myeloma

Thank you

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 InstituteSeattle, Washington  98104
Washington Hospital CenterWashington, District of Columbia  20010
Wilshire Oncology Medical GroupGlendora, California  91741
Avera Research InstituteSioux Falls, South Dakota  57105
Peninsula Cancer InstituteNewport News, Virginia  23601
Cooper Cancer CenterVoorhees, New Jersey  08043
East Texas Medical Center Cancer InstituteTyler, Texas  75701
Center for Cancer & Blood DisordersBethesda, Maryland  20817
Berkshire Hematology OncologyPittsfield, Massachusetts  01201
University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201
Blood and Cancer Center of East TexasTyler, Texas  75701
Oncology Care Medical AssociatesMontebello, California  90640
Hematology Oncology PCStamford, Connecticut  06902
Medical Associates, PACharleston, South Carolina  29403
Lexington Oncology AssociatesWest Columbia, South Carolina  29169
Cleveland Clinic FloridaWeston, Florida  33331
Palo Alto Medical Foundation Hematology/OncologyMountain View, California  94040
Low Country Hematology Oncology Dept of Lowcountry Hem/OncMt. Pleasant, South Carolina  29464
SUNY - Upstate Medical University Div. of Hematology-OncologySyracuse, New York  13210
Dana Farber Cancer Institute Clinical Research CoordinatorBoston, Massachusetts  02115
TriValley Cancer Research and Treatment CenterCasa Grande, Arizona  85222
Cedars Sinai Medical Center Outpatient Cancer Ctr. (4)Los Angeles, California  90048
Santa Clara Valley Health & Hospital SystemSan Jose, California  95128
University of Colorado U of Colorado Cancer CenterAurora, Colorado  80045
Palm Beach Institute of Hematology OncologyBoynton Beach, Florida  33435
Innovative Medical Research of South Florida Innovative Med ResearchMiami Shores, Florida  33138
Cancer Centers of Florida PA Cancer Centers of Central FLOcoee, Florida  *see dep*
Integrated Community Oncology Network Florida Oncology AssociatesOrange Park, Florida  32073
Loyola University Medical Center /Cardinal Bernardin Cancer Loyola Univ Med CtrMaywood, Illinois  60153
Oncology - Hematology Associates, PA Oncology Hematology AssocClinton, Maryland  20735
Boston VA Healthcare Boston VABoston, Massachusetts  02131
N MS Hematology & OncologyTupelo, Mississippi  38801
Hematology & Oncology Consultants, PC Hematology & OncologyOmaha, 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 CenterRochester, New York  14642
Rochester General Hospital / Lipson Cancer Center Lipson Cancer CenterRochester, New York  14621
Carolina Oncology Specialists, PCHickory, North Carolina  28602
Regional Hematology-Oncology Associates PCLanghorne, Pennsylvania  19047
Temple University Temple UniversityPhiladelphia, 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 UnitMorgantown, West Virginia  26506