Alvocade® (Bortezomib) Safety and Effectiveness Study

Completed

• Conditions: Multiple Myeloma, Refractory
• Interventions: Drug: Bortezomib

• Registration Number: NCT06012383
• Lead Sponsor: NanoAlvand

Brief 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.

Study Timeline

• Study Start: 2016-07
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Status Verified: 2023-08
• Study First Submitted: 2023-08-13
• Study First Submitted QC: 2023-08-19
• Last Update Submitted: 2023-08-19
• Study First Posted: 2023-08-25
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Patients with multiple myeloma were included in the study.

Exclusion Criteria

• There were no exclusion criteria for this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NanoAlvand Bortezomib	Bortezomib	1.3 mg/m2 Bortezomib, IV infusion

Primary Outcome Measures

Name	Time	Method
Safety Assessment	up to 6 months	Safety assessment, including the incidence of AEs. All AEs were classified based on the Medical Dictionary for Regulatory Activities (MedDRA Desktop Browser 4.0 Beta) terms as System Organ Class (SOC) and Preferred Term (PT). All the reported events were graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Moreover, seriousness of AEs was assessed according to International Council for Harmonisation (ICH-E2B) guidelines. The causality relation was assessed based on the World Health Organization (WHO) criteria.

Secondary Outcome Measures

Name	Time	Method
Effectiveness Assessment	up to 6 months	Response categories (Stable Disease (SD), Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR), and stringent Complete Response (sCR)) were defined and reported based on the uniform response criteria of the International Myeloma Working Group.