Alvocade® (Bortezomib) Safety and Effectiveness Study

NanoAlvand

Status: Completed

Conditions: Multiple Myeloma, Refractory

Treatments: Drug: Bortezomib

Study type: Observational

Funder types: Industry

Identifiers

NCT06012383

BOR.NA.MR.95.IV

Details and patient eligibility

About

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).

Full 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.

Enrollment: 57 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with multiple myeloma were included in the study.

Exclusion criteria

• There were no exclusion criteria for this study.

Trial design

57 participants in 1 patient group

NanoAlvand Bortezomib

Description:

1.3 mg/m2 Bortezomib, IV infusion

Treatment:

Drug: Bortezomib