Clinical trial NCT00104104: A Multiple Myeloma Trial in Patients With Bone Metastases
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Myeloma
Keywords: Z-MAX, multiple myeloma, zoledronic acid, bone metastases
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-02-23
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months
timeFrame: Baseline and 12 Months
measure: The Number of Participants With Disease Progression
timeFrame: 24 Months
Secondary outcomes:
measure: The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months
timeFrame: Baseline and 24 Months
measure: Time to First Significant Increase in Serum Creatinine
timeFrame: Up to 24 months
measure: Zoledronic Acid Concentrations
timeFrame: 24 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Hematology Oncology Specialists
state: Alabama
city: Glendale
country: United States
facility: Palo Verde Hematology Oncology
state: Arizona
city: Tucson
country: United States
facility: US Oncology
state: Arizona
city: Little Rock
country: United States
facility: Myeloma Institute For Research Therapy
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas
state: Arkansas
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center
state: California
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: Campbell
country: United States
facility: Southbay Oncology Hematology Partners
state: California
city: Concord
country: United States
facility: Bay Area Cancer Research Group
state: California
city: Fresno
country: United States
facility: California Oncology of the Central Valley
state: California
city: LaJolla
country: United States
facility: Dr. Robert P. Brouillard Inc.
state: California
city: Lancaster
country: United States
facility: Antelope Valley Cancer Center
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Mission Hills
country: United States
facility: North Valley H/O
state: California
city: Orange
country: United States
facility: Hematology/Oncology Group of Orange County
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group
state: California
city: Sunnyvale
country: United States
facility: Camino Medical Group
state: California
city: West Hollywood
country: United States
facility: Oncotherapeutics
state: California
city: Greeley
country: United States
facility: Greeley Medical Center
state: Colorado
city: Fort Meyers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Hollywood
country: United States
facility: South Florida Oncology Hematology
state: Florida
city: Kissimmee
country: United States
facility: Osceola Cancer Center
state: Florida
city: Miami
country: United States
facility: Miami Cancer Care
state: Florida
city: New Port Richey
country: United States
facility: Pasco Hernado Oncology
state: Florida
city: Ormond Beach
country: United States
facility: MetCare Oncology
state: Florida
city: Pensacola
country: United States
facility: Hematology Oncology Associates PA
state: Florida
city: Rockledge
country: United States
facility: Hem/Onc Associates of Central Brevard
state: Florida
city: Augusta
country: United States
facility: Augusta Oncology Associates
state: Georgia
city: Tucker
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: New Albany
country: United States
facility: Cancer Care Center
state: Indiana
city: Hutchinson
country: United States
facility: Hutchinson Clinic, PA
state: Kansas
city: New Orleans
country: United States
facility: Hematology and Oncology Specialists
state: Louisiana
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine - Blood Disorders
state: Maine
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Clinton
country: United States
facility: Oncology Hematology Associates, PA
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology-Hematology PA
state: Maryland
city: Lambertville
country: United States
facility: Hematology Oncology Associates of Ohio & Michigan
state: Michigan
city: Southfield
country: United States
facility: Providence Cancer Center, Clinical Trials Dept
state: Michigan
city: Kansas City
country: United States
facility: Kansas City Cancer Center
state: Missouri
city: St. Joseph
country: United States
facility: St. Joseph Oncology, Inc.
state: Missouri
city: St. Louis
country: United States
facility: The Center for Cancer Care and Research
state: Missouri
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Nevada Cancer Center
state: Nevada
city: Cherry Hill
country: United States
facility: Center for Cancer & Hematology Disease
state: New Jersey
city: East Brunswick
country: United States
facility: Central Jersey Oncology Center
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Voorhees
country: United States
facility: CINJ at Cooper University Hospital
state: New Jersey
city: Santa Fe
country: United States
facility: New Mexico Cancer Care Associates
state: New Mexico
city: Bay Shore
country: United States
facility: Hematology Oncology of Western Suffolk
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Syracuse
country: United States
facility: Syracuse Hematology/Oncology PC
state: New York
city: Kettering
country: United States
facility: Dayton Oncology & Hematology, PA
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania, Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Oncology Associates
state: Pennsylvania
city: West Reading
country: United States
facility: Berks Oncology and Hematology Associates
state: Pennsylvania
city: Cranston
country: United States
facility: Hematology & Oncology Associates of RI
state: Rhode Island
city: Providence
country: United States
facility: Roger Williams Hospital Medical Center
state: Rhode Island
city: Charleston
country: United States
facility: Charleston Hematology Oncology
state: South Carolina
city: Knoxville
country: United States
facility: Baptist Regional Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: Center for Oncology Research & Treatment, PA
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
city: Ogden
country: United States
facility: Utah Hematology Oncology
state: Utah
city: Salem
country: United States
facility: Oncology Hematology Associates of Southwest VA
state: Virginia
city: Lacey
country: United States
facility: Western Washington Oncology
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Appleton
country: United States
facility: Fox Valley Hematology Oncology SC
state: Wisconsin
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References: