Alvocade® (Bortezomib) Safety and Effectiveness Study

NCT06012383 | Completed

• 1 other identifier: BOR.NA.MR.95.IV
• Study Type: observational
• Target: 57
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Multiple Myeloma, Refractory

Keywords

Multiple Myeloma; Bortezomib; Safety; Alvocade

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effectiveness Assessment

  up to 6 months

Study Arms (1)

NanoAlvand Bortezomib

1.3 mg/m2 Bortezomib, IV infusion

Drug: Bortezomib

Interventions

Bortezomib DRUG

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

Also known as: Alvocade®

NanoAlvand Bortezomib

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A population of 57 Iranian patients diagnosed with multiple myeloma under chemotherapy regimens with Alvocade® (with a dose of 1.3 mg/m2), were enrolled in the study.

You may qualify if:

• Patients with multiple myeloma were included in the study.

Sponsors & Collaborators

• NanoAlvand: lead

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mani Ramzi, Prof.

  Shiraz University of Medical Sciences, Shiraz, Iran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 25, 2023
• Study Start: July 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 25, 2023

Record last verified: 2023-08