Study Results
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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COMPLETED
57 participants
OBSERVATIONAL
2016-07-31
2022-12-31
Brief Summary
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Detailed Description
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Exposure to Alvocade® in this study was defined as administration of bortezomib (Alvocade®, NanoAlvand) with a dose of 1.3 mg/m2, once every 3 weeks during 2.5 to 5.5 months (16 injections).
The primary objective of this study was safety assessment, including the incidence of adverse events (AEs).
This study was single arm and the sample size of this study was 59 patients.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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NanoAlvand Bortezomib
1.3 mg/m2 Bortezomib, IV infusion
Bortezomib
Alvocade® was given with a dose of 1.3 mg/m2.
Interventions
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Bortezomib
Alvocade® was given with a dose of 1.3 mg/m2.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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NanoAlvand
INDUSTRY
Responsible Party
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Principal Investigators
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Mani Ramzi, Prof.
Role: PRINCIPAL_INVESTIGATOR
Shiraz University of Medical Sciences, Shiraz, Iran
Other Identifiers
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BOR.NA.MR.95.IV
Identifier Type: -
Identifier Source: org_study_id
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