Status:
TERMINATED
Zoledronic Acid in the Management of Patients With Asymptomatic/Early Stage Multiple Myeloma
Lead Sponsor:
Hoosier Cancer Research Network
Collaborating Sponsors:
Novartis Pharmaceuticals
Walther Cancer Institute
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 biochemica...
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 performan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00216151
Start Date
June 1 2005
End Date
March 1 2007
Last Update
May 2 2011
Active Locations (8)
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1
Elkhart Clinic
Elkhart, Indiana, United States, 46515
2
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States, 47714
3
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
4
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, United States, 46202