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

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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00216151

Enrollment

Registered

2005-09-22

Start date

2005-06-30

Completion date

2007-03-31

Last updated

2011-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma, Bisphosphonates

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

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

Interventions

DRUGZoledronic Acid

Zoledronic Acid 4mg, every three months

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026