Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants
- Registration Number
- NCT00622505
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study evaluated the effectiveness and safety of a dosing method for zoledronic acid in preventing skeletal complications in multiple myeloma participants who have been on an intravenous (IV) bisphosphonate for about one to two years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
- Confirmed diagnosis of multiple myeloma
- Have been on zoledronic acid or pamidronate for 1-2 years and therapy must have been initiated for osteolytic lesion, bone fracture, spinal compression, or osteopenia due to multiple myeloma
- Stable renal function
- Known sensitivity to bisphosphonates
- Receiving investigational drugs considered not safe for co-administration or have a significant effect on bone turnover
- Current active dental problems
- Had bone marrow transplant or blood stem cell transplant within 2 months before study entry or planned transplant within 2 months following enrollment
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zoledronic acid zoledronic acid Participants received 4 milligrams (mg) or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes, every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine N-telopeptide of type 1 collagen (NTx) measurement (greater than or equal to \[≥\] 50 nanomoles per millimoles \[nmol/mmol\] creatinine or \<50 nmol/mmol creatinine, respectively).
- Primary Outcome Measures
Name Time Method Percentage of Participants With ≥1 SRE at the End of 1 Year on Study 1 year SRE was defined as pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or hypercalcemia of malignancy (HCM). SRE was assessed by centrally read radiographic bone surveys.
- Secondary Outcome Measures
Name Time Method Time to First SRE on Study Up to 2 years The time to first SRE is defined as the date of enrollment to the date of the first occurrence of any SRE on the study. SRE includes pathological fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or HCM. Participants who drop-out was treated as censored observations. Time to first SRE on the study was assessed by the Kaplan-Meier method.
Percentage of Participants Who Experienced Pathologic Bone Fracture Years 1 and 2 Pathologic bone fractures are defined as bone fractures that occur spontaneously or as a result of trivial trauma.
Percentage of Participants Who Experienced Spinal Cord Compression Years 1 and 2 Spinal cord compression is caused by the impingement of a tumor on the spinal cord and is associated with neurologic impairment and/or back pain.
Percentage of Participants Who Experienced Radiation to Bone Years 1 and 2 Radiation therapy to bone events includes irradiation of bone to palliate painful lesions, to treat or prevent pathologic fractures, or to treat or prevent spinal cord compression.
Percentage of Participants Who Experienced HCM Years 1 and 2 HCM is defined as corrected serum calcium ≥ 12.0 milligrams per deciliter (mg/dL) (3.00 millimoles per liter \[mmol/L\]), or a lower level of hypercalcemia that was symptomatic and required active treatment other than rehydration.
Time to Death Up to 2 years Time to death was defined as the time from the date of enrollment to the date of death. Participants who dropped out or completed the study were considered censored observations. Time to death was assessed by Kaplan-Meier method.
Percentage of Participants Who Experienced Surgery to Bone Years 1 and 2 Surgery to bone events includes surgical procedures that are performed to set or stabilize pathologic fractures or areas of spinal cord compression and surgical procedures that are performed to prevent an imminent pathologic fracture or spinal cord compression.
Skeletal Related Event (SRE) Rate Years 1 and 2 The SRE rate for each participant was calculated as the number of SREs/total follow-up time. SRE included pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or HCM.
Change From Baseline in Urinary N-telopeptide of Type 1 Collagen (uNTx) Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 and 100/End of Study (EOS) uNTx is a biomarker used to measure the rate of bone turnover found in urine.
Trial Locations
- Locations (42)
Loyola University Medical Center /Cardinal Bernardin Cancer Loyola Univ Med Ctr
🇺🇸Maywood, Illinois, United States
University of Maryland Greenebaum Cancer Center
🇺🇸Baltimore, Maryland, United States
Dana Farber Cancer Institute Clinical Research Coordinator
🇺🇸Boston, Massachusetts, United States
Boston VA Healthcare Boston VA
🇺🇸Boston, Massachusetts, United States
Cooper Cancer Center
🇺🇸Voorhees, New Jersey, United States
SUNY - Upstate Medical University Div. of Hematology-Oncology
🇺🇸Syracuse, New York, United States
West Virginia University Health Research Center Clinical Trial Research Unit
🇺🇸Morgantown, West Virginia, United States
Northern Utah Cancer Associates Dept.ofNorthernUtahAssoc.
🇺🇸Ogden, Utah, United States
Center for Cancer & Blood Disorders
🇺🇸Bethesda, Maryland, United States
Hematology & Oncology Consultants, PC Hematology & Oncology
🇺🇸Omaha, Nebraska, United States
TriValley Cancer Research and Treatment Center
🇺🇸Casa Grande, Arizona, United States
Wilshire Oncology Medical Group
🇺🇸La Verne, California, United States
Cedars Sinai Medical Center Outpatient Cancer Ctr. (4)
🇺🇸Los Angeles, California, United States
Oncology Care Medical Associates
🇺🇸San Gabriel, California, United States
Hematology Oncology PC
🇺🇸Stamford, Connecticut, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Palm Beach Institute of Hematology Oncology
🇺🇸Boynton Beach, Florida, United States
Cancer Centers of Florida PA Cancer Centers of Central FL
🇺🇸Ocoee, Florida, United States
Integrated Community Oncology Network Florida Oncology Associates
🇺🇸Orange Park, Florida, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Oncology - Hematology Associates, PA Oncology Hematology Assoc
🇺🇸Clinton, Maryland, United States
Berkshire Hematology Oncology
🇺🇸Pittsfield, Massachusetts, United States
Somerset Hematology Oncology Associates Somerset Hema Oncol Assoc (2)
🇺🇸Somerset, New Jersey, United States
University of Rochester MC / James P. Wilmot Cancer Center James P. Wilmot Cancer Center
🇺🇸Rochester, New York, United States
Rochester General Hospital / Lipson Cancer Center Lipson Cancer Center
🇺🇸Rochester, New York, United States
Carolina Oncology Specialists, PC
🇺🇸Hickory, North Carolina, United States
Regional Hematology-Oncology Associates PC
🇺🇸Langhorne, Pennsylvania, United States
Temple University Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Lexington Oncology Associates
🇺🇸West Columbia, South Carolina, United States
Low Country Hematology Oncology Dept of Lowcountry Hem/Onc
🇺🇸Mount Pleasant, South Carolina, United States
East Texas Medical Center Cancer Institute
🇺🇸Tyler, Texas, United States
Peninsula Cancer Institute
🇺🇸Newport News, Virginia, United States
Central Utah Clinic Central Utah Clinic (8)
🇺🇸Provo, Utah, United States
Palo Alto Medical Foundation Hematology/Oncology
🇺🇸Mountain View, California, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Innovative Medical Research of South Florida Innovative Med Research
🇺🇸Miami Shores, Florida, United States
University of Colorado U of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
N MS Hematology & Oncology
🇺🇸Tupelo, Mississippi, United States
Santa Clara Valley Health & Hospital System
🇺🇸San Jose, California, United States
Avera Research Institute
🇺🇸Sioux Falls, South Dakota, United States
Blood and Cancer Center of East Texas
🇺🇸Tyler, Texas, United States
Medical Associates, PA
🇺🇸Charleston, South Carolina, United States