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Completed

NCT Number: NCT01234129

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

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

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tertiary reference oncology center

Mexico City, 06725, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Zoledronic acid

Drug

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

Primary outcomes

  1. 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 outcomes

  1. skeletal event

    Time frame: 3 years

    evaluate the number of skeletal events in patients with multiple myeloma that received zoledronic acid

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2009
Study completion
2009
First posted
Nov 4, 2010
Registry last updated
Nov 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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