Multiple Myeloma Clinical Trial
Zoledronic Acid in the Management of Patients With Asymptomatic/Early Stage Multiple Myeloma
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
Full 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
Eligibility Criteria
Inclusion Criteria:
Diagnosis of asymptomatic multiple myeloma as defined by the criteria below:
Presence of bone marrow clonal plasma cells (more than 10%)
Presence of an M-protein in serum and/or urine (no concentration specified)
Serum calcium < 12 mg/dl within 14 days prior to registration. Less than 3 lytic lesions, no pathologic fractures and no osteopenia noted on skeletal survey
No symptoms of hyperviscosity, amyloidosis or recurrent infection
Bone mineral density with a T score higher than -2.0 standard deviation (not have osteoporosis) within 28 days prior to registration
Negative pregnancy test
Exclusion Criteria:
No previous treatment with bisphosphonates
No disorders of the parathyroid or thyroid glands
No current breastfeeding
No prior malignancy is allowed except for adequately treated in situ cervical cancer, Gleason < grade 7 prostate cancers
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There are 7 Locations for this study
Elkhart Indiana, 46515, United States
Evansville Indiana, 47714, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46202, United States
Lafayette Indiana, 47904, United States
South Bend Indiana, 46601, United States
Terre Haute Indiana, 47802, United States
Terre Haute Indiana, 47804, United States
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