A Survey on NINLARO Risk Management Plan (RMP) Material Utilization Among Pharmacists in Japan
- Conditions
- Multiple Myeloma
- Interventions
- Other: No Intervention
- Registration Number
- NCT05882279
- Lead Sponsor
- Takeda
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pharmacists in Hospitals Prescribing NINLARO No Intervention 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.
- Primary Outcome Measures
Name Time Method Number of Pharmacists Who Had Provided Patients With the Contents of the Risk Management Plan (RMP) Material Up to Day 9 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.
- Secondary Outcome Measures
Name Time Method Number of Pharmacist With Understanding of the Proper NINLARO Dosing Schedule Up to Day 9 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.
Number of Pharmacists Who Had Received the RMP Material for Patients Up to Day 9 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.
Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule Up to Day 9 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.
Trial Locations
- Locations (1)
Takeda selected site
🇯🇵Tokyo, Japan