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
1 other identifier
observational
330
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2023
CompletedFirst Posted
Study publicly available on registry
May 31, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2023
CompletedResults Posted
Study results publicly available
June 14, 2024
CompletedJune 14, 2024
May 1, 2024
8 days
May 22, 2023
May 23, 2024
May 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Number of Pharmacists Who Had Received the RMP Material for Patients
Up to Day 9
Number of Pharmacist With Understanding of the Proper NINLARO Dosing Schedule
Up to Day 9
Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule
Up to Day 9
Study Arms (1)
Pharmacists in Hospitals Prescribing NINLARO
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.
Interventions
Eligibility Criteria
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.
You may qualify if:
- Who belong to hospitals prescribing NINLARO.
- Who have instructed the dosing of NINLARO in IRD therapy to patients.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Takeda selected site
Tokyo, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2023
First Posted
May 31, 2023
Study Start
June 1, 2023
Primary Completion
June 9, 2023
Study Completion
June 9, 2023
Last Updated
June 14, 2024
Results First Posted
June 14, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.