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

NCT ID: NCT01234129

Last Updated: 2010-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-06-30

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Multiple Myeloma

Keywords

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multiple myeloma stem cell transplant zoledronic acid

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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zoledronic acid or not zoledronic acid

patients with multiple myeloma will be treated with cytoreductive therapy following by zoledronic acid or not.

No interventions assigned to this group

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

zoledronic acid

Intervention Type DRUG

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

zoledronic acid

Intervention Type DRUG

zoledronic acid, 4 mg,standard dose,at monthly interval, by 2 years

Interventions

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zoledronic acid

zoledronic acid, 4 mg,standard dose,at monthly interval, by 2 years

Intervention Type DRUG

Eligibility Criteria

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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

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Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mexican Institute of Social Security

Principal Investigators

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Agustin Aviles, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Mexicano del Seguro Social

Locations

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Tertiary reference oncology center

Mexico City, Mexico City, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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kitty2

Identifier Type: OTHER

Identifier Source: secondary_id

kitty1

Identifier Type: -

Identifier Source: org_study_id