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

April 28, 2011 updated by: Hoosier Cancer Research Network

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Elkhart, Indiana, United States, 46515
        • Elkhart Clinic
      • Evansville, Indiana, United States, 47714
        • Oncology Hematology Associates of SW Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • Quality Cancer Center (MCGOP)
      • Lafayette, Indiana, United States, 47904
        • Arnett Cancer Care
      • South Bend, Indiana, United States, 46601
        • Northern Indiana Cancer Research Consortium
      • Terre Haute, Indiana, United States, 47802
        • Providence Medical Group
      • Terre Haute, Indiana, United States, 47804
        • AP&S Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome 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.
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoosier Cancer Research Network

Collaborators

Novartis Pharmaceuticals
Walther Cancer Institute

Investigators

  • Study Chair: Attaya Suvannasankha, M.D., Hoosier Oncology Group, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

May 2, 2011

Last Update Submitted That Met QC Criteria

April 28, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOG MM02-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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