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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01234129
First Posted: November 4, 2010
Last Update Posted: November 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Instituto Mexicano del Seguro Social
  Purpose
Assess the impact in outcome of the use of zoledronic acid in multiple myeloma.

Condition Intervention
Multiple Myeloma Drug: zoledronic acid

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Results of Phase III Study to Assess if Zoledronic Acid Have Antumor Activity in Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Instituto Mexicano del Seguro Social:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • skeletal event [ Time Frame: 3 years ]
    evaluate the number of skeletal events in patients with multiple myeloma that received zoledronic acid


Enrollment: 320
Study Start Date: June 2002
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with multiple myeloma previously untreated
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234129


Locations
Mexico
Tertiary reference oncology center
Mexico, Distrito Federal, Mexico, 06725
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
Principal Investigator: Agustin Aviles, MD Instituto Mexicano del Seguro Social
  More Information

Responsible Party: Agustin Aviles, Senior Researcher, Mexican Institute of Social Security
ClinicalTrials.gov Identifier: NCT01234129     History of Changes
Other Study ID Numbers: kitty1
kitty2 ( Other Identifier: Mexican Institute of Social Security )
First Submitted: November 3, 2010
First Posted: November 4, 2010
Last Update Posted: November 4, 2010
Last Verified: December 2009

Keywords provided by Instituto Mexicano del Seguro Social:
multiple myeloma
stem cell transplant
zoledronic acid

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs