A Phase IV, Post Marketing, Prospective, Observational Cohort Study to Investigate Safety and Effectiveness of Alvocade® in Iranian Patients With Multiple Myeloma
Overview
- Phase
- Not Applicable
- Intervention
- Bortezomib
- Conditions
- Multiple Myeloma, Refractory
- Sponsor
- NanoAlvand
- Enrollment
- 57
- Primary Endpoint
- Safety Assessment
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with multiple myeloma were included in the study.
Exclusion Criteria
- •There were no exclusion criteria for this study.
Arms & Interventions
NanoAlvand Bortezomib
1.3 mg/m2 Bortezomib, IV infusion
Intervention: Bortezomib
Outcomes
Primary Outcomes
Safety Assessment
Time Frame: 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 Outcomes
- Effectiveness Assessment(up to 6 months)