NCT06012383

Alvocade® (Bortezomib) Safety and Effectiveness Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 57 (actual)
• Sponsor: NanoAlvand · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Multiple Myeloma, Refractory

Interventions

Type	Name	Description
DRUG	Bortezomib	Alvocade® was given with a dose of 1.3 mg/m2.

Timeline

• Start date: 2016-07-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2023-08-25
• Last updated: 2023-08-25