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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01234129
Enrollment
320
Registered
2010-11-04
Start date
2002-06-30
Completion date
2009-12-31
Last updated
2010-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

multiple myeloma, stem cell transplant, zoledronic acid

Brief summary

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

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.

Interventions

DRUGzoledronic acid

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

Sponsors

Instituto Mexicano del Seguro Social
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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 \-

Design outcomes

Primary

MeasureTime frameDescription
progression-free disease and overall toxicity in myeloma multiple3 yearsIn 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

MeasureTime frameDescription
skeletal event3 yearsevaluate the number of skeletal events in patients with multiple myeloma that received zoledronic acid

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026