Stem Cell Transplant and Zoledronic Acid Improve Outcome in Previously Untreated Patients With Multiple Myeloma

November 3, 2010 updated by: Instituto Mexicano del Seguro Social

Results of Phase III Study to Assess if Zoledronic Acid Have Antumor Activity in Multiple Myeloma

Assess the impact in outcome of the use of zoledronic acid in multiple myeloma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Assess if the use of zoledronic acid can improve outcome in patients with multiple myeloma whose are treated with cytoreductive therapy and stem cell transplant.

Study Type

Observational

Enrollment (Actual)

320

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

  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 06725
        • Tertiary reference oncology center

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with multiple myeloma previously untreated

Description

Inclusion Criteria:

Diagnosis of multiple myeloma No previous treatment Symptomatic High risk (ISS) or stage III ( Durie-Salmon) No severe comorbidities -

Exclusion Criteria:

Pregnancy HIV + Refuse treatment

-

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
zoledronic acid or not zoledronic acid
patients with multiple myeloma will be treated with cytoreductive therapy following by zoledronic acid or not.
Drug: zoledronic acid
zoledronic acid, 4 mg,standard dose,at monthly interval, by 2 years
zoledronic acid or not zoledronic acid
patients with multiple myeloma will be treated with cytoreductive therapy following by stem cell transplant and did not received zoledronic acid
Drug: zoledronic acid
zoledronic acid, 4 mg,standard dose,at monthly interval, by 2 years
zoledronic acid
Patients with multiple treated with cytoreductive therapy following by stem cell transplant will be planned to received zoledronic acid
Drug: zoledronic acid
zoledronic acid, 4 mg,standard dose,at monthly interval, by 2 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free disease and overall toxicity in myeloma multiple
Time Frame: 3 years
In patients treated with cytoreductive therapy following by stem cell transplant and that received zoledronic acid by 2 years,they were evaluable for assess antitumor effect of zoledronic acid
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
skeletal event
Time Frame: 3 years
evaluate the number of skeletal events in patients with multiple myeloma that received zoledronic acid
3 years

Collaborators and Investigators

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

Sponsor

Instituto Mexicano del Seguro Social

Investigators

  • Principal Investigator: Agustin Aviles, MD, Instituto Mexicano del Seguro Social

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, 2002

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

November 3, 2010

First Posted (Estimate)

November 4, 2010

Study Record Updates

Last Update Posted (Estimate)

November 4, 2010

Last Update Submitted That Met QC Criteria

November 3, 2010

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kitty1
  • kitty2 (Other Identifier: Mexican Institute of Social Security)

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.

Clinical Trials on Multiple Myeloma

Clinical Trials on zoledronic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe