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A Multicenter,Open Label, Randomized Trial Evaluating the Duration of Infusion of Zoledronic Acid 4 mg IV in Multiple Myeloma Patients With Bone Metastases


Phase 4
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

A Multicenter,Open Label, Randomized Trial Evaluating the Duration of Infusion of Zoledronic Acid 4 mg IV in Multiple Myeloma Patients With Bone Metastases


Inclusion Criteria:



- Patients 18 years of age or older

- Confirmed diagnosis of Multiple Myeloma

- Stable renal function defined as two serum creatinine determinations of < 3 mg/dL

- Calculated creatinine clearance of greater than or equal to 30 mL/min

- ECOG Performance Status of 0 or 1

- Life expectancy of greater than or equal to 9 months

- If the patient is of child-bearing potential, a negative pregnancy test is required
at screening, while postmenopausal women must be amenorrheic for at least 12 months
to be considered of non-childbearing potential.

- Ability to comply with trial requirements and give informed consent.

Exclusion Criteria:

- IV Bisphosphonate therapy for more than 3 years.

- Patients with a diagnosis of amyloidosis.

- Known hypersensitivity to zoledronic acid or other bisphosphonates

- Pregnant patients or lactating patients.

- Women of childbearing potential not on a medically recognized form of contraception

- Patients with uncontrolled cardiovascular disease, hypertension, and Type 2 diabetes
mellitus.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months

Outcome Description:

The primary renal safety endpoint was the number of participants with a clinically relevant increase in serum creatinine at 12 months. Serum creatinine was determined prior to each zoledronic acid infusion for all Participants and was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.

Outcome Time Frame:

Baseline and 12 Months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Chair

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Institutional Review Board

Study ID:

CZOL446EUS97

NCT ID:

NCT00104104

Start Date:

October 2004

Completion Date:

October 2007

Related Keywords:

  • Multiple Myeloma
  • Z-MAX, multiple myeloma, zoledronic acid, bone metastases
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Neoplasm Metastasis
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location

Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
Swedish Cancer InstituteSeattle, Washington  98104
Hackensack University Medical CenterHackensack, New Jersey  07601
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Georgia Cancer SpecialistsDecatur, Georgia  30033
Florida Cancer SpecialistsFort Myers, Florida  33901
Nevada Cancer CenterLas Vegas, Nevada  89109
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Cancer Care CenterNew Albany, Indiana  47150
Pacific Shores Medical GroupLong Beach, California  90813
New Mexico Cancer Care AssociatesSanta Fe, New Mexico  87505-7670
University of ArkansasLittle Rock, Arkansas  72202
Nebraska Methodist HospitalOmaha, Nebraska  68114
St. Joseph Oncology, Inc.Saint Joseph, Missouri  64506
Central Jersey Oncology CenterNew Brunswick, New Jersey  08901
Baptist Regional Cancer CenterKnoxville, Tennessee  37920
Western Washington OncologyOlympia, Washington  98502
Osceola Cancer CenterKissimmee, Florida  34741
Augusta Oncology AssociatesAugusta, Georgia  30901
Charleston Hematology OncologyCharleston, South Carolina  29403
California Oncology of the Central ValleyFresno, California  93710
Hematology and Oncology SpecialistsNew Orleans, Louisiana  70115
Bay Area Cancer Research GroupConcord, California  94520
New York Presbyterian HospitalNew York, New York  10021
MetCare OncologyOrmond Beach, Florida  32174
Kansas City Cancer CenterKansas City, Missouri  64111
Center for Oncology Research & Treatment, PADallas, Texas  75230
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Palo Verde Hematology OncologyGlendale, Arizona  85304
Ut Southwestern Medical CenterDallas, Texas  75390
OncotherapeuticsLos Angeles, California  90067
South Florida Oncology HematologyHollywood, Florida  33021
Southbay Oncology Hematology PartnersCampbell, California  95008
Antelope Valley Cancer CenterLancaster, California  93534
The Center for Cancer Care and ResearchSt. Louis, Missouri  63141
Hematology Oncology SpecialistsHuntsville, Alabama  35801
US OncologyTucson, Arizona  85710
Myeloma Institute For Research TherapyLittle Rock, Arkansas  72205
Pacific Cancer Medical CenterAnaheim, California  92801
Dr. Robert P. Brouillard Inc.LaJolla, California  92037
North Valley H/OMission Hills, California  91345
Hematology/Oncology Group of Orange CountyOrange, California  92868
Desert Hematology Oncology Medical GroupRancho Mirage, California  92270
Camino Medical GroupSunnyvale, California  94086
Greeley Medical CenterGreeley, Colorado  80631
Miami Cancer CareMiami, Florida  33133
Pasco Hernado OncologyNew Port Richey, Florida  34652
Hematology Oncology Associates PAPensacola, Florida  32501
Hem/Onc Associates of Central BrevardRockledge, Florida  32955
Hutchinson Clinic, PAHutchinson, Kansas  67502
Maine Center for Cancer Medicine - Blood DisordersScarborough, Maine  04074
Oncology Hematology Associates, PAClinton, Maryland  20735
Maryland Oncology-Hematology PAColumbia, Maryland  21044
Hematology Oncology Associates of Ohio & MichiganLambertville, Michigan  48144
Providence Cancer Center, Clinical Trials DeptSouthfield, Michigan  48075
Center for Cancer & Hematology DiseaseCherry Hill, New Jersey  08003
CINJ at Cooper University HospitalVoorhees, New Jersey  08043
Hematology Oncology of Western SuffolkBay Shore, New York  11706
Syracuse Hematology/Oncology PCSyracuse, New York  13210
Dayton Oncology & Hematology, PAKettering, Ohio  45409
Pennsylvania Oncology AssociatesPhiladelphia, Pennsylvania  19106
University of Pennsylvania, PhiladelphiaPhiladelphia, Pennsylvania  19104
Berks Oncology and Hematology AssociatesWest Reading, Pennsylvania  19611
Hematology & Oncology Associates of RICranston, Rhode Island  02920
Roger Williams Hospital Medical CenterProvidence, Rhode Island  02908
Utah Hematology OncologyOgden, Utah  84403
Oncology Hematology Associates of Southwest VASalem, Virginia  24153
Fox Valley Hematology Oncology SCAppleton, Wisconsin  54915