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NCT05882279 Clinical Trial

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

Multiple Myeloma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05882279
Other study ID # C16065
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date June 9, 2023

Study information
Verified date May 2024
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 330
Est. completion date June 9, 2023
Est. primary completion date June 9, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: 1. Who belong to hospitals prescribing NINLARO. 2. Who have instructed the dosing of NINLARO in IRD therapy to patients. Exclusion criteria: None

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No Intervention
This is a non-interventional study.

Locations
Country Name City State
Japan Takeda selected site Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Pharmacists Who Had Provided Patients With the Contents of the Risk Management Plan (RMP) Material The NINLARO additional risk minimization measure (aRMM) effectiveness study questionnaire which was intended for pharmacists who instructed the dosing of IRD therapy to patients with relapsed/refractory multiple myeloma (RRMM). This outcome was based on the number of pharmacists who answered "Yes" to question 3; Do you instruct patients that they should take one capsule of NINLARO each time on an empty stomach for RRMM? Here, unit of measure: participants refer to pharmacists. Up to Day 9
Secondary Number of Pharmacists Who Had Received the RMP Material for Patients The NINLARO aRMM effectiveness study questionnaire which was intended for pharmacists who instructed the dosing of IRD therapy to patients with RRMM. This outcome was based on the number of pharmacists who answered "Yes" to question 7; Have you obtained the RMP material for patients? Here, unit of measure: participants refer to pharmacists. Up to Day 9
Secondary Number of Pharmacist With Understanding of the Proper NINLARO Dosing Schedule The NINLARO aRMM effectiveness study questionnaire which was intended for pharmacists who instructed the dosing of IRD therapy to patients with RRMM. This outcome was based on the number of pharmacists who answered "Yes" to question 1; Do you know that patients will take one capsule of NINLARO each time on an empty stomach for RRMM? Here, unit of measure: participants refer to pharmacists. Up to Day 9
Secondary Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule The NINLARO aRMM effectiveness study questionnaire which was intended for pharmacists who instructed the dosing of IRD therapy to patients with RRMM. This outcome was based on question 2; Do you think it is important to inform patients that they should take one capsule of NINLARO each time on an empty stomach for RRMM? Here, unit of measure: participants refer to pharmacists. Up to Day 9
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