Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT00216151
Status:
TERMINATED
Last Update Posted:
2011-05-02
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Zoledronic Acid in the Management of Patients With Asymptomatic/Early Stage Multiple Myeloma
Sponsor:
Hoosier Cancer Research Network
Organization:
Study Overview
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
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 asymptomatic/early stage Multiple Myeloma
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
* 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
Study Oversight
Has Oversight DMC:
True
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?: