Spots Global Cancer Trial Database for Zoledronic Acid in the Management of Patients With Asymptomatic/Early Stage Multiple Myeloma
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Trial Identification
Brief Title: Zoledronic Acid in the Management of Patients With Asymptomatic/Early Stage Multiple Myeloma
Official Title: A Randomized Phase II Study of Bisphosphonate: Zoledronic Acid (Zometa) in the Management of Asymptomatic/Early Stage Multiple Myeloma: Hoosier Oncology Group MM02-35
Study ID: NCT00216151
Conditions
Interventions
Study Description
Brief Summary: Evidence for the beneficial effects of bisphosphonates on bone resorption in multiple myeloma has been reported extensively, showing reductions in skeletal events and improvement of several biochemical variables in bone resorption. Zoledronic acid (Zometa®, CGP42446) is the most potent clinically available bisphosphonates, with the largest therapeutic ratio between the desired inhibition of calcium resorption and the unwanted inhibition of mineralization in vitro of all the bisphosphonates. This trial will investigate the efficacy of zoledronic acid in preventing skeletal events in patients with asymptomatic/early stage Multiple Myeloma
Detailed Description: OUTLINE: This is a multi-center study. * Patients will be randomly assigned by study number to receive 4mg of zoledronic acid every three months or to be observed. Performance status: ECOG performance status 0-3 (KPS 30 - 100) Life expectancy: 12 months Hematopoietic: * Hb \>10 g/dl within 14 days prior to registration Hepatic: * Not specified Renal: * Serum creatinine \< 2 mg/dl within 14 days prior to registration Cardiovascular: * Not specified Pulmonary: * Not specified
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Elkhart Clinic, Elkhart, Indiana, United States
Oncology Hematology Associates of SW Indiana, Evansville, Indiana, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Quality Cancer Center (MCGOP), Indianapolis, Indiana, United States
Arnett Cancer Care, Lafayette, Indiana, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
Providence Medical Group, Terre Haute, Indiana, United States
AP&S Clinic, Terre Haute, Indiana, United States
Contact Details
Name: Attaya Suvannasankha, M.D.
Affiliation: Hoosier Oncology Group, LLC
Role: STUDY_CHAIR
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