Alvocade® (Bortezomib) Safety and Effectiveness Study

NCT ID: NCT06012383

Last Updated: 2023-08-25

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

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2022-12-31

Brief Summary

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This study is a phase IV, post-marketing, observational, cohort study for safety and effectiveness evaluation of Alvocade® use in Iranian patients with multiple myeloma. No control groups were considered in the study design. The primary objective of this study was safety assessment, including the incidence of adverse events (AEs).

Detailed Description

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This study is a phase IV, post-marketing, observational, cohort study for safety and effectiveness evaluation of Alvocade® use in Iranian patients with multiple myeloma. Data were gathered in two booklets, containing information on sixteen injections, which were filled by the designated physician.

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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Multiple Myeloma, Refractory

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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NanoAlvand Bortezomib

1.3 mg/m2 Bortezomib, IV infusion

Bortezomib

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Alvocade®

Eligibility Criteria

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Inclusion Criteria

* Patients with multiple myeloma were included in the study.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NanoAlvand

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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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