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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-03-31

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

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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

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

Patients will be randomly assigned by study number to receive 4mg of zoledronic acid every three months.

Group Type ACTIVE_COMPARATOR

Zoledronic Acid

Intervention Type DRUG

Zoledronic Acid 4mg, every three months

B

Patients will be randomly assigned by study number to observation only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Zoledronic Acid

Zoledronic Acid 4mg, every three months

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No