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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Who belong to hospitals prescribing NINLARO. Who have instructed the dosing of NINLARO in IRD therapy to patients. Exclusion criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pharmacists in Hospitals Prescribing NINLARO<br>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. | Other: No Intervention<br>* This is a non-interventional study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Pharmacists who Have Provided Patients With the Contents of the RMP Material |  | 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Pharmacists who Have Received the RMP Material for Patients |  | 12 days | 
| Number of Pharmacist With Understanding of the Proper NINLARO Dosing Schedule |  | 12 days | 
| Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule |  | 12 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy