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

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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A Randomized Phase II Study of Bisphosphonate: Zoledronic Acid (Zometa) in the Management of Asymptomatic/Early Stage Multiple Myeloma: Hoosier Oncology Group MM02-35

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Zoledronic Acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Patients will be randomly assigned by study number to receive 4mg of zoledronic acid every three months. | Drug: Zoledronic Acid<br>* Zoledronic Acid 4mg, every three months<br>|
| No Intervention: B<br>Patients will be randomly assigned by study number to observation only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| · 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| · 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, Bisphosphonates