Multiple Myeloma
Conditions
Keywords
Drug Therapy
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.
Interventions
OTHERNo Intervention
This is a non-interventional study.
Sponsors
Takeda
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
Countries
Japan
Participant flow
Recruitment details
Recruitment and response collection started on 01 June 2023 and ended on 09 June 2023.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 330 |
| Total | 330 |
Baseline characteristics
| Characteristic | Pharmacists in Hospitals Prescribing NINLARO |
|---|---|
| Age, Customized Greater than or equal to (>=) 22 years | 330 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 330 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 330 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Japan | 330 Participants |
| Sex: Female, Male Female | 198 Participants |
| Sex: Female, Male Male | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: Up to Day 9
Population: The final analysis set included all pharmacists who consented to participate in the survey, passed the screening questions, and completed all questions.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pharmacists in Hospitals Prescribing NINLARO | Number of Pharmacists Who Had Provided Patients With the Contents of the Risk Management Plan (RMP) Material | 307 Participants |
Secondary
Number of Pharmacists Who Had Received the RMP Material for Patients
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.
Time frame: Up to Day 9
Population: The final analysis set included all pharmacists who consented to participate in the survey, passed the screening questions, and completed all questions.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pharmacists in Hospitals Prescribing NINLARO | Number of Pharmacists Who Had Received the RMP Material for Patients | 124 Participants |
Secondary
Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule
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.
Time frame: Up to Day 9
Population: The final analysis set included all pharmacists who consented to participate in the survey, passed the screening questions, and completed all questions.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pharmacists in Hospitals Prescribing NINLARO | Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule | Very important | 298 Participants |
| Pharmacists in Hospitals Prescribing NINLARO | Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule | Rather important | 30 Participants |
| Pharmacists in Hospitals Prescribing NINLARO | Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule | Rather not important | 1 Participants |
| Pharmacists in Hospitals Prescribing NINLARO | Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule | Not important | 1 Participants |
Secondary
Number of Pharmacist With Understanding of the Proper NINLARO Dosing Schedule
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.
Time frame: Up to Day 9
Population: The final analysis set included all pharmacists who consented to participate in the survey, passed the screening questions, and completed all questions.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pharmacists in Hospitals Prescribing NINLARO | Number of Pharmacist With Understanding of the Proper NINLARO Dosing Schedule | 316 Participants |