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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | This is a non-interventional study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion criteria:
None
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda selected site | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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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.
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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.
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.
Recruitment and response collection started on 01 June 2023 and ended on 09 June 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The final analysis set included all pharmacists who consented to participate in the survey, passed the screening questions, and completed all questions.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Here, unit of measure: participants refer to pharmacists. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The final analysis set included all pharmacists who consented to participate in the survey, passed the screening questions, and completed all questions. | Posted | Count of Participants | Participants | Up to Day 9 |
|
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events data were not collected/assessed in this study
This was a web-based multiple choice questionnaire survey of pharmacists which did not include safety information as adverse events were not planned to be collected in this study. Data '0' for total number of participants at risk/affected for sections all-cause mortality, serious adverse events, and other (not including serious adverse events) signifies that adverse events were not collected and assessed in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2023 | May 23, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| Up to Day 9 |
| 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. | Up to Day 9 |
| 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. | Up to Day 9 |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Here, unit of measure: participants refer to pharmacists. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Here, unit of measure: participants refer to pharmacists. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Here, unit of measure: participants refer to pharmacists. | Count of Participants | Participants |
|
| Region of Enrollment | Here, unit of measure: participants refer to pharmacists. | Count of Participants | 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. | The final analysis set included all pharmacists who consented to participate in the survey, passed the screening questions, and completed all questions. | Posted | Count of Participants | Participants | Up to Day 9 |
|
|
|
| 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. | The final analysis set included all pharmacists who consented to participate in the survey, passed the screening questions, and completed all questions. | Posted | Count of Participants | Participants | Up to Day 9 |
|
|
|
| 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. | The final analysis set included all pharmacists who consented to participate in the survey, passed the screening questions, and completed all questions. | Posted | Count of Participants | Participants | Up to Day 9 |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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.
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Not important |
|