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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:
Information provided by:
Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier:
NCT01234129
First received: November 3, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted
  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:

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Agustin Aviles, Senior Researcher, Mexican Institute of Social Security
ClinicalTrials.gov Identifier: NCT01234129     History of Changes
Other Study ID Numbers: kitty1, kitty2
Study First Received: November 3, 2010
Last Updated: November 3, 2010
Health Authority: Mexico:Mexican Institute of Social Security

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013