NCT05882279

A Survey on NINLARO Risk Management Plan (RMP) Material Utilization Among Pharmacists in Japan

Evaluation of the Effectiveness of Risk Minimization Measures: A Survey Among Pharmacists to Assess the Impact of the RMP Material for Patients on Promoting the Proper Use of NINLARO in Japan

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 330 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a survey among pharmacists who have instructed NINLARO therapy in ixazomib, lenalidomide and dexamethasone (IRD) dosing to patients with relapsed/refractory multiple myeloma (rrMM). The main aims of the study are: * To assess the frequency of pharmacists who have provided patients with the contents of the RMP material for patients. * To assess the frequency of pharmacists who have obtained the RMP material for patients. * To evaluate the depth of understanding of proper usage of NINLARO among pharmacists.

Detailed description

This is a prospective, non-interventional, observational web-based survey in pharmacists who have instructed the dosing of NINLARO (ixazomib) in combination with lenalidomide and dexamethasone therapy to patients with rrMM. The study will assess the effectiveness of distributed RMP material in prevention of ixazomib overdose in Japanese clinical practice. The study will enroll approximately 300 pharmacists who belong to hospitals prescribing NINLARO. The data will be collected through a self-administered web-based survey with questionnaires provided in Japanese. This web-based survey will be conducted in Japan.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
OTHER	No Intervention	This is a non-interventional study.

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-06-09
• Completion: 2023-06-09
• First posted: 2023-05-31
• Last updated: 2024-06-14
• Results posted: 2024-06-14

Locations

1 site across 1 country: Japan