Alvocade® (Bortezomib) Safety and Effectiveness Study

NanoAlvand57 enrolled

Overview

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).

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 Type

OBSERVATIONAL

Enrollment

Conditions

Multiple Myeloma, Refractory

Interventions

BortezomibDRUG

Alvocade® was given with a dose of 1.3 mg/m2.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with multiple myeloma were included in the study. Exclusion Criteria: * There were no exclusion criteria for this study.

Outcomes

Primary Outcomes

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.

Time frame: up to 6 months

Secondary Outcomes

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.

Time frame: up to 6 months

Data from ClinicalTrials.gov

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