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Alvocade® (Bortezomib) Safety and Effectiveness Study

Sponsor
NanoAlvand (Industry)
Overall Status
Completed
CT.gov ID
NCT06012383
Collaborator
(none)
57
Enrollment
77
Actual Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
57 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Phase IV, Post Marketing, Prospective, Observational Cohort Study to Investigate Safety and Effectiveness of Alvocade® in Iranian Patients With Multiple Myeloma
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Dec 1, 2022
Actual Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
NanoAlvand Bortezomib

1.3 mg/m2 Bortezomib, IV infusion

Drug: Bortezomib
Alvocade® was given with a dose of 1.3 mg/m2.
Other Names:
  • Alvocade®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with multiple myeloma were included in the study.
    Exclusion Criteria:
    • There were no exclusion criteria for this study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • NanoAlvand

    Investigators

    • Principal Investigator: Mani Ramzi, Prof., Shiraz University of Medical Sciences, Shiraz, Iran

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NanoAlvand
    ClinicalTrials.gov Identifier:
    NCT06012383
    Other Study ID Numbers:
    • BOR.NA.MR.95.IV
    First Posted:
    Aug 25, 2023
    Last Update Posted:
    Aug 25, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by NanoAlvand
    Multiple Myeloma
    Bortezomib
    Safety
    Alvocade
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Bortezomib

    Study Results

    No Results Posted as of Aug 25, 2023