Zoledronic Acid in the Management of Patients With Asymptomatic/Early Stage Multiple Myeloma

Stopped early · Phase 2

Conditions studied: Multiple Myeloma

In brief

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

Key facts

Study ID

NCT00216151

Run by

Hoosier Cancer Research Network

People needed

3

Starts

2005-06-01

Expected to finish

2007-03-01

Last updated by the study team

2011-05-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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