Multiple Myeloma Clinical Trial
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
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
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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