Alvocade® (Bortezomib) Safety and Effectiveness Study

Multiple Myeloma, Refractory Clinical Trial

Official title: A Phase IV, Post Marketing, Prospective, Observational Cohort Study to Investigate Safety and Effectiveness of Alvocade® in Iranian Patients With Multiple Myeloma

Status Completed

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma, Refractory
• Neoplasms, Plasma Cell

• NCT number: NCT06012383
• Study type: Observational
• Source: NanoAlvand
• Status: Completed
• Start date: July 2016
• Completion date: December 2022