A Multiple Myeloma Trial in Patients With Bone Metastases
- Registration Number
- NCT00104104
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 179
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 15 Minute Infusion zoledronic acid Participants 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 zoledronic acid Participants 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.
- Primary Outcome Measures
Name Time Method The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months Baseline and 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.
The Number of Participants With Disease Progression 24 Months
- Secondary Outcome Measures
Name Time Method The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months Baseline and 24 Months Serum Creatinine 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.
Time to First Significant Increase in Serum Creatinine Up to 24 months Median time to event in participants who had a clinically relevant increase in serum creatinine.
Zoledronic Acid Concentrations 24 months Samples for drug concentration analysis were drawn at 10 and 15 minutes into the infusion for participants in the 15-minute infusion group and at 25 and 30 minutes into the infusion for patients in the 30-minute infusion group. The mean and median zoledronic acid concentrations were greater in the 15-minute group than in the 30-minute group at both sampling timepoints.
Trial Locations
- Locations (68)
Osceola Cancer Center
🇺🇸Kissimmee, Florida, United States
Maryland Oncology-Hematology PA
🇺🇸Columbia, Maryland, United States
Fox Valley Hematology Oncology SC
🇺🇸Appleton, Wisconsin, United States
Nevada Cancer Center
🇺🇸Las Vegas, Nevada, United States
Miami Cancer Care
🇺🇸Miami, Florida, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Hutchinson Clinic, PA
🇺🇸Hutchinson, Kansas, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Center for Cancer & Hematology Disease
🇺🇸Cherry Hill, New Jersey, United States
University of Arkansas
🇺🇸Little Rock, Arkansas, United States
Maine Center for Cancer Medicine - Blood Disorders
🇺🇸Scarborough, Maine, United States
Central Jersey Oncology Center
🇺🇸East Brunswick, New Jersey, United States
CINJ at Cooper University Hospital
🇺🇸Voorhees, New Jersey, United States
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
US Oncology
🇺🇸Tucson, Arizona, United States
Oncotherapeutics
🇺🇸West Hollywood, California, United States
South Florida Oncology Hematology
🇺🇸Hollywood, Florida, United States
Greeley Medical Center
🇺🇸Greeley, Colorado, United States
Western Washington Oncology
🇺🇸Lacey, Washington, United States
Baptist Regional Cancer Center
🇺🇸Knoxville, Tennessee, United States
Oncology Hematology Associates of Southwest VA
🇺🇸Salem, Virginia, United States
Utah Hematology Oncology
🇺🇸Ogden, Utah, United States
Center for Oncology Research & Treatment, PA
🇺🇸Dallas, Texas, United States
Hematology Oncology Specialists
🇺🇸Huntsville, Alabama, United States
Myeloma Institute For Research Therapy
🇺🇸Little Rock, Arkansas, United States
Pacific Cancer Medical Center
🇺🇸Anaheim, California, United States
Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, California, United States
Southbay Oncology Hematology Partners
🇺🇸Campbell, California, United States
Bay Area Cancer Research Group
🇺🇸Concord, California, United States
Dr. Robert P. Brouillard Inc.
🇺🇸LaJolla, California, United States
California Oncology of the Central Valley
🇺🇸Fresno, California, United States
Antelope Valley Cancer Center
🇺🇸Lancaster, California, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
Desert Hematology Oncology Medical Group
🇺🇸Rancho Mirage, California, United States
North Valley H/O
🇺🇸Mission Hills, California, United States
Hematology/Oncology Group of Orange County
🇺🇸Orange, California, United States
Florida Cancer Specialists
🇺🇸Fort Meyers, Florida, United States
Pasco Hernado Oncology
🇺🇸New Port Richey, Florida, United States
MetCare Oncology
🇺🇸Ormond Beach, Florida, United States
Camino Medical Group
🇺🇸Sunnyvale, California, United States
Hem/Onc Associates of Central Brevard
🇺🇸Rockledge, Florida, United States
Hematology Oncology Associates PA
🇺🇸Pensacola, Florida, United States
Augusta Oncology Associates
🇺🇸Augusta, Georgia, United States
Cancer Care Center
🇺🇸New Albany, Indiana, United States
Georgia Cancer Specialists
🇺🇸Tucker, Georgia, United States
Oncology Hematology Associates, PA
🇺🇸Clinton, Maryland, United States
Hematology and Oncology Specialists
🇺🇸New Orleans, Louisiana, United States
Providence Cancer Center, Clinical Trials Dept
🇺🇸Southfield, Michigan, United States
Hematology Oncology Associates of Ohio & Michigan
🇺🇸Lambertville, Michigan, United States
The Center for Cancer Care and Research
🇺🇸St. Louis, Missouri, United States
St. Joseph Oncology, Inc.
🇺🇸St. Joseph, Missouri, United States
New Mexico Cancer Care Associates
🇺🇸Santa Fe, New Mexico, United States
Hematology Oncology of Western Suffolk
🇺🇸Bay Shore, New York, United States
Pennsylvania Oncology Associates
🇺🇸Philadelphia, Pennsylvania, United States
Syracuse Hematology/Oncology PC
🇺🇸Syracuse, New York, United States
Dayton Oncology & Hematology, PA
🇺🇸Kettering, Ohio, United States
Berks Oncology and Hematology Associates
🇺🇸West Reading, Pennsylvania, United States
University of Pennsylvania, Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Hematology & Oncology Associates of RI
🇺🇸Cranston, Rhode Island, United States
Roger Williams Hospital Medical Center
🇺🇸Providence, Rhode Island, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
Kansas City Cancer Center
🇺🇸Kansas City, Missouri, United States
Charleston Hematology Oncology
🇺🇸Charleston, South Carolina, United States
Palo Verde Hematology Oncology
🇺🇸Glendale, Arizona, United States