A Multiple Myeloma Trial in Patients With Bone Metastases
A Multicenter,Open Label, Randomized Trial Evaluating the Duration of Infusion of Zoledronic Acid 4 mg IV in Multiple Myeloma Patients With Bone Metastases
2 other identifiers
interventional
179
1 country
68
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 multiple-myeloma
Started Oct 2004
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 22, 2005
CompletedFirst Posted
Study publicly available on registry
February 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedResults Posted
Study results publicly available
June 6, 2011
CompletedJune 29, 2011
June 1, 2011
3 years
February 22, 2005
January 6, 2011
June 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months
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.
Baseline and 12 Months
The Number of Participants With Disease Progression
24 Months
Secondary Outcomes (3)
The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months
Baseline and 24 Months
Time to First Significant Increase in Serum Creatinine
Up to 24 months
Zoledronic Acid Concentrations
24 months
Study Arms (2)
15 Minute Infusion
EXPERIMENTALParticipants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks
30 Minute Infusion
EXPERIMENTALParticipants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
Interventions
4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
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.
La Jolla, 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.
Saint 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 Township, 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
University of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Pennsylvania Oncology Associates
Philadelphia, Pennsylvania, 19106, 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novatis Pharmaceuticals
Study Officials
- STUDY CHAIR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 22, 2005
First Posted
February 23, 2005
Study Start
October 1, 2004
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
June 29, 2011
Results First Posted
June 6, 2011
Record last verified: 2011-06