A Multiple Myeloma Trial in Patients With Bone Metastases
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Z-MAX, multiple myeloma, zoledronic acid, bone metastases
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.
Sites / Locations
- Hematology Oncology Specialists
- Palo Verde Hematology Oncology
- US Oncology
- Myeloma Institute For Research Therapy
- University of Arkansas
- Pacific Cancer Medical Center
- Comprehensive Blood and Cancer Center
- Southbay Oncology Hematology Partners
- Bay Area Cancer Research Group
- California Oncology of the Central Valley
- Dr. Robert P. Brouillard Inc.
- Antelope Valley Cancer Center
- Pacific Shores Medical Group
- North Valley H/O
- Hematology/Oncology Group of Orange County
- Desert Hematology Oncology Medical Group
- Camino Medical Group
- Oncotherapeutics
- Greeley Medical Center
- Florida Cancer Specialists
- South Florida Oncology Hematology
- Osceola Cancer Center
- Miami Cancer Care
- Pasco Hernado Oncology
- MetCare Oncology
- Hematology Oncology Associates PA
- Hem/Onc Associates of Central Brevard
- Augusta Oncology Associates
- Georgia Cancer Specialists
- Cancer Care Center
- Hutchinson Clinic, PA
- Hematology and Oncology Specialists
- Maine Center for Cancer Medicine - Blood Disorders
- Center for Cancer and Blood Disorders
- Oncology Hematology Associates, PA
- Maryland Oncology-Hematology PA
- Hematology Oncology Associates of Ohio & Michigan
- Providence Cancer Center, Clinical Trials Dept
- Kansas City Cancer Center
- St. Joseph Oncology, Inc.
- The Center for Cancer Care and Research
- Nebraska Methodist Hospital
- Comprehensive Cancer Centers of Nevada
- Nevada Cancer Center
- Center for Cancer & Hematology Disease
- Central Jersey Oncology Center
- Hackensack University Medical Center
- CINJ at Cooper University Hospital
- New Mexico Cancer Care Associates
- Hematology Oncology of Western Suffolk
- New York Presbyterian Hospital
- Syracuse Hematology/Oncology PC
- Dayton Oncology & Hematology, PA
- University of Pennsylvania, Philadelphia
- Pennsylvania Oncology Associates
- Berks Oncology and Hematology Associates
- Hematology & Oncology Associates of RI
- Roger Williams Hospital Medical Center
- Charleston Hematology Oncology
- Baptist Regional Cancer Center
- Center for Oncology Research & Treatment, PA
- UT Southwestern Medical Center
- Joe Arrington Cancer Research and Treatment Center
- Utah Hematology Oncology
- Oncology Hematology Associates of Southwest VA
- Western Washington Oncology
- Swedish Cancer Institute
- Fox Valley Hematology Oncology SC
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
15 Minute Infusion
30 Minute Infusion
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
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.