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A Multiple Myeloma Trial in Patients With Bone Metastases

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: zoledronic acid (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis Pharmaceuticals

Summary

The purpose of this trial is to study the safety of treating patients with multiple myeloma

and at least one bone lesion with zoledronic acid 4mg intravenously (IV) every 3 - 4 weeks

for 2 years. Patients will receive a zoledronic acid infusion for 15 minutes or 30 minutes.

Clinical Details

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

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

Primary outcome:

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

The Number of Participants With Disease Progression

Secondary outcome:

The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months

Time to First Significant Increase in Serum Creatinine

Zoledronic Acid Concentrations

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Hematology Oncology Specialists, Huntsville, Alabama 35801, United States

Palo Verde Hematology Oncology, Glendale, Arizona 85304, United States

US Oncology, Tucson, Arizona 85710, United States

Myeloma Institute For Research Therapy, Little Rock, Arkansas 72205, United States

University of Arkansas, Little Rock, Arkansas 72205, United States

Pacific Cancer Medical Center, Anaheim, California 92801, United States

Comprehensive Blood and Cancer Center, Bakersfield, California 93309, United States

Southbay Oncology Hematology Partners, Campbell, California 95008, United States

Bay Area Cancer Research Group, Concord, California 94520, United States

California Oncology of the Central Valley, Fresno, California 93710, United States

Dr. Robert P. Brouillard Inc., LaJolla, California 92037, United States

Antelope Valley Cancer Center, Lancaster, California 93534, United States

Pacific Shores Medical Group, Long Beach, California 90813, United States

North Valley H/O, Mission Hills, California 91345, United States

Hematology/Oncology Group of Orange County, Orange, California 92868, United States

Desert Hematology Oncology Medical Group, Rancho Mirage, California 92270, United States

Camino Medical Group, Sunnyvale, California 94086, United States

Oncotherapeutics, West Hollywood, California 90069, United States

Greeley Medical Center, Greeley, Colorado 80631, United States

Florida Cancer Specialists, Fort Meyers, Florida 33901, United States

South Florida Oncology Hematology, Hollywood, Florida 33021, United States

Osceola Cancer Center, Kissimmee, Florida 34741, United States

Miami Cancer Care, Miami, Florida 33133, United States

Pasco Hernado Oncology, New Port Richey, Florida 34652, United States

MetCare Oncology, Ormond Beach, Florida 32174, United States

Hematology Oncology Associates PA, Pensacola, Florida 32501, United States

Hem/Onc Associates of Central Brevard, Rockledge, Florida 32955, United States

Augusta Oncology Associates, Augusta, Georgia 30901, United States

Georgia Cancer Specialists, Tucker, Georgia 30084, United States

Cancer Care Center, New Albany, Indiana 47150, United States

Hutchinson Clinic, PA, Hutchinson, Kansas 67502, United States

Hematology and Oncology Specialists, New Orleans, Louisiana 70115, United States

Maine Center for Cancer Medicine - Blood Disorders, Scarborough, Maine 04074, United States

Center for Cancer and Blood Disorders, Bethesda, Maryland 20817, United States

Oncology Hematology Associates, PA, Clinton, Maryland 20735, United States

Maryland Oncology-Hematology PA, Columbia, Maryland 21044, United States

Hematology Oncology Associates of Ohio & Michigan, Lambertville, Michigan 48144, United States

Providence Cancer Center, Clinical Trials Dept, Southfield, Michigan 48075, United States

Kansas City Cancer Center, Kansas City, Missouri 64131, United States

St. Joseph Oncology, Inc., St. Joseph, Missouri 64507, United States

The Center for Cancer Care and Research, St. Louis, Missouri 63141, United States

Nebraska Methodist Hospital, Omaha, Nebraska 68114, United States

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada 89109, United States

Nevada Cancer Center, Las Vegas, Nevada 89128, United States

Center for Cancer & Hematology Disease, Cherry Hill, New Jersey 08003, United States

Central Jersey Oncology Center, East Brunswick, New Jersey 08816, United States

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States

CINJ at Cooper University Hospital, Voorhees, New Jersey 08043, United States

New Mexico Cancer Care Associates, Santa Fe, New Mexico 87505, United States

Hematology Oncology of Western Suffolk, Bay Shore, New York 11706, United States

New York Presbyterian Hospital, New York, New York 10021, United States

Syracuse Hematology/Oncology PC, Syracuse, New York 13210, United States

Dayton Oncology & Hematology, PA, Kettering, Ohio 45409, United States

Pennsylvania Oncology Associates, Philadelphia, Pennsylvania 19106, United States

University of Pennsylvania, Philadelphia, Philadelphia, Pennsylvania 19104, United States

Berks Oncology and Hematology Associates, West Reading, Pennsylvania 19611, United States

Hematology & Oncology Associates of RI, Cranston, Rhode Island 02920, United States

Roger Williams Hospital Medical Center, Providence, Rhode Island 02908, United States

Charleston Hematology Oncology, Charleston, South Carolina 29403, United States

Baptist Regional Cancer Center, Knoxville, Tennessee 37920, United States

Center for Oncology Research & Treatment, PA, Dallas, Texas 75230, United States

UT Southwestern Medical Center, Dallas, Texas 75390-9179, United States

Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas 79410, United States

Utah Hematology Oncology, Ogden, Utah 84403, United States

Oncology Hematology Associates of Southwest VA, Salem, Virginia 24153, United States

Western Washington Oncology, Lacey, Washington 98503, United States

Swedish Cancer Institute, Seattle, Washington 98104, United States

Fox Valley Hematology Oncology SC, Appleton, Wisconsin 54915, United States

Additional Information

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Starting date: October 2004
Last updated: June 27, 2011

Page last updated: August 23, 2015

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