Alvocade® (Bortezomib) Safety and Effectiveness Study

Study Overview
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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.

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

Conditions
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Multiple Myeloma, Refractory

Intervention / Treatment
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* Drug: Bortezomib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with multiple myeloma were included in the study. Exclusion Criteria: There were no exclusion criteria for this study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NanoAlvand Bortezomib<br>1.3 mg/m2 Bortezomib, IV infusion | Drug: Bortezomib<br>* Alvocade® was given with a dose of 1.3 mg/m2.<br>* Other names: Alvocade®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment | 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. | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness Assessment | 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. | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, Bortezomib, Safety, Alvocade