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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00216151
• Other study ID #: HOG MM02-35
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: April 28, 2011
• Start date: June 2005
• Est. completion date: March 2007

Study information

• Verified date: April 2011
• Source: Hoosier Cancer Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Zoledronic Acid
Zoledronic Acid 4mg, every three months

Locations

Country	Name	City	State
United States	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	AP&S Clinic	Terre Haute	Indiana
United States	Providence Medical Group	Terre Haute	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Hoosier Cancer Research Network	Novartis Pharmaceuticals, Walther Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	· To examine the effect of intravenous zoledronic acid at the dose of 4 mg given every three months compared with observation, on percent change in bone mineral density of the spine at one year in patients with asymptomatic, smoldering and stage I MM.		18 months	No
Secondary	· To examine the effect of intravenous zoledronic acid at the above schedule on percent change in bone mineral density of the total hip and femur.		18 months	No

External Links

•   Hoosier Oncology Group Home Page