Trial Outcomes & Findings for A Survey on NINLARO Risk Management Plan (RMP) Material Utilization Among Pharmacists in Japan (NCT NCT05882279)
NCT ID: NCT05882279
Last Updated: 2024-06-14
Results Overview
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.
COMPLETED
330 participants
Up to Day 9
2024-06-14
Participant Flow
Recruitment and response collection started on 01 June 2023 and ended on 09 June 2023.
A total of 24,000 pharmacists were requested to cooperate. Of these, 1329 pharmacists consented to participate in this study and 336 pharmacists passed the screening questions, out of which 6 pharmacists did not complete the questionnaire. 330 pharmacists were enrolled and completed all questions and were included in the analysis.
Participant milestones
| Measure |
Pharmacists in Hospitals Prescribing NINLARO
Pharmacists included in Nikkei Medical Online Panel, active in clinical practice, and with valid contact details who belonged to hospitals and have instructed the dosing of NINLARO (ixazomib) in combination with lenalidomide and dexamethasone (IRD therapy) to patients were selected to participate in the survey.
|
|---|---|
|
Overall Study
STARTED
|
330
|
|
Overall Study
COMPLETED
|
330
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Survey on NINLARO Risk Management Plan (RMP) Material Utilization Among Pharmacists in Japan
Baseline characteristics by cohort
| Measure |
Pharmacists in Hospitals Prescribing NINLARO
n=330 Participants
Pharmacists included in Nikkei Medical Online Panel, active in clinical practice, and with valid contact details who belonged to hospitals and have instructed the dosing of NINLARO (ixazomib) in combination with lenalidomide and dexamethasone (IRD therapy) to patients were selected to participate in the survey.
|
|---|---|
|
Age, Customized
Greater than or equal to (>=) 22 years
|
330 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
198 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
330 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
330 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Japan
|
330 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to Day 9Population: The final analysis set included all pharmacists who consented to participate in the survey, passed the screening questions, and completed all questions.
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.
Outcome measures
| Measure |
Pharmacists in Hospitals Prescribing NINLARO
n=330 Participants
Pharmacists included in Nikkei Medical Online Panel, active in clinical practice, and with valid contact details who belonged to hospitals and have instructed the dosing of NINLARO (ixazomib) in combination with lenalidomide and dexamethasone (IRD therapy) to patients were selected to participate in the survey.
|
|---|---|
|
Number of Pharmacists Who Had Provided Patients With the Contents of the Risk Management Plan (RMP) Material
|
307 Participants
|
SECONDARY outcome
Timeframe: Up to Day 9Population: The final analysis set included all pharmacists who consented to participate in the survey, passed the screening questions, and completed all questions.
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.
Outcome measures
| Measure |
Pharmacists in Hospitals Prescribing NINLARO
n=330 Participants
Pharmacists included in Nikkei Medical Online Panel, active in clinical practice, and with valid contact details who belonged to hospitals and have instructed the dosing of NINLARO (ixazomib) in combination with lenalidomide and dexamethasone (IRD therapy) to patients were selected to participate in the survey.
|
|---|---|
|
Number of Pharmacists Who Had Received the RMP Material for Patients
|
124 Participants
|
SECONDARY outcome
Timeframe: Up to Day 9Population: The final analysis set included all pharmacists who consented to participate in the survey, passed the screening questions, and completed all questions.
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.
Outcome measures
| Measure |
Pharmacists in Hospitals Prescribing NINLARO
n=330 Participants
Pharmacists included in Nikkei Medical Online Panel, active in clinical practice, and with valid contact details who belonged to hospitals and have instructed the dosing of NINLARO (ixazomib) in combination with lenalidomide and dexamethasone (IRD therapy) to patients were selected to participate in the survey.
|
|---|---|
|
Number of Pharmacist With Understanding of the Proper NINLARO Dosing Schedule
|
316 Participants
|
SECONDARY outcome
Timeframe: Up to Day 9Population: The final analysis set included all pharmacists who consented to participate in the survey, passed the screening questions, and completed all questions.
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.
Outcome measures
| Measure |
Pharmacists in Hospitals Prescribing NINLARO
n=330 Participants
Pharmacists included in Nikkei Medical Online Panel, active in clinical practice, and with valid contact details who belonged to hospitals and have instructed the dosing of NINLARO (ixazomib) in combination with lenalidomide and dexamethasone (IRD therapy) to patients were selected to participate in the survey.
|
|---|---|
|
Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule
Very important
|
298 Participants
|
|
Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule
Rather important
|
30 Participants
|
|
Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule
Rather not important
|
1 Participants
|
|
Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule
Not important
|
1 Participants
|
Adverse Events
Pharmacists in Hospitals Prescribing NINLARO
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER