NCT05882279 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: Not reported
Status at capture: COMPLETED
Registry last update: 2024-06-14

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Pharmacists Who Had Provided Patients With the Contents of the Risk Management Plan (RMP) Material

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outcome · POSTED

Number of Pharmacists Who Had Received the RMP Material for Patients

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outcome · POSTED

Number of Pharmacist With Understanding of the Proper NINLARO Dosing Schedule

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outcome · POSTED

Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 18 Years
sampling Method: NON_PROBABILITY_SAMPLE
sex: ALL
std Ages: ADULT
OLDER_ADULT
study Population: Pharmacists included in Nikkei Research Access Panel, active in clinical practice, and with valid contact details who belong to hospitals prescribing NINLARO and instructed the dosing of NINLARO in IRD therapy to patients with rrMM will be randomly selected to participate in the survey.

Treatment arms and interventions

arm Groups

description
Pharmacists included in Nikkei Research Access Panel who are active in clinical practice, with valid contact and who have instructed the dosing of NINLARO IRD therapy to patients with rrMM will self-administer a web-based survey. The questionnaires in the survey will be provided in Japanese.
intervention Names
Other: No Intervention
label
Pharmacists in Hospitals Prescribing NINLARO

interventions

arm Group Labels
Pharmacists in Hospitals Prescribing NINLARO
description
This is a non-interventional study.
name
No Intervention
type
OTHER

Study design

observational Model: OTHER
time Perspective: PROSPECTIVE

Enrollment

count: 330
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Number of Pharmacists Who Had Provided Patients With the Contents of the Risk Management Plan (RMP) Material
time Frame
Up to Day 9

secondary Outcomes

description
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.
measure
Number of Pharmacists Who Had Received the RMP Material for Patients
time Frame
Up to Day 9
description
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.
measure
Number of Pharmacist With Understanding of the Proper NINLARO Dosing Schedule
time Frame
Up to Day 9
description
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.
measure
Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule
time Frame
Up to Day 9

Full study description

brief 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.

Source references