NCT00216151

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

A Randomized Phase II Study of Bisphosphonate: Zoledronic Acid (Zometa) in the Management of Asymptomatic/Early Stage Multiple Myeloma: Hoosier Oncology Group MM02-35

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Hoosier Cancer Research Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Zoledronic Acid	Zoledronic Acid 4mg, every three months

Timeline

• Start date: 2005-06-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2005-09-22
• Last updated: 2011-05-02

Locations

8 sites across 1 country: United States