Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216151
Status:
TERMINATED
Last Update Posted:
2011-05-02
First Post:
2005-09-12
Brief Title:
Zoledronic Acid in the Management of Patients With AsymptomaticEarly Stage Multiple Myeloma
Sponsor:
Hoosier Cancer Research Network
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
A Randomized Phase II Study of Bisphosphonate Zoledronic Acid Zometa in the Management of AsymptomaticEarly Stage Multiple Myeloma Hoosier Oncology Group MM02-35
Status:
TERMINATED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to low patient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 asymptomaticearly stage Multiple Myeloma
This trial will investigate the efficacy of zoledronic acid in preventing skeletal events in patients with asymptomaticearly 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 gdl within 14 days prior to registration
Hepatic
Not specified
Renal
Serum creatinine 2 mgdl within 14 days prior to registration
Cardiovascular
Not specified
Pulmonary
Not specified
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 gdl within 14 days prior to registration
Hepatic
Not specified
Renal
Serum creatinine 2 mgdl within 14 days prior to registration
Cardiovascular
Not specified
Pulmonary
Not specified
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None