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NCT01234129 Clinical Trial

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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01234129
Other study ID # kitty1
Secondary ID kitty2
Status Completed
Phase N/A
First received November 3, 2010
Last updated November 3, 2010
Start date June 2002
Est. completion date December 2009

Study information
Verified date December 2009
Source Instituto Mexicano del Seguro Social
Contact n/a
Is FDA regulated No
Health authority Mexico:Mexican Institute of Social Security
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 320
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Mexico Tertiary reference oncology center Mexico Distrito Federal

Sponsors (1)
Lead Sponsor Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary progression-free disease and overall toxicity in myeloma multiple 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 No
Secondary skeletal event evaluate the number of skeletal events in patients with multiple myeloma that received zoledronic acid 3 years Yes
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