Multiple MyelomaNCT05882279
A Survey on NINLARO Risk Management Plan (RMP) Material Utilization Among Pharmacists in Japan
An observational study of Multiple Myeloma, run by Takeda at 1 site in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 330 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jun 2023to 9 Jun 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Who belong to hospitals prescribing NINLARO.
- Who have instructed the dosing of NINLARO in IRD therapy to patients.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- No Intervention
- Keywords
- Drug Therapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 9
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Jun 2023
- Primary completion9 Jun 2023
- Study completion9 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882279
- Sponsor's protocol ID
- C16065
- Status last verified
- May 2024
- First submitted
- 22 May 2023
- Last updated
- 14 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05882279
- Acronym / sponsor ID
- C16065
- Conditions
- Multiple Myeloma
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 9 Jun 2023 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Posted 14 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacists in Hospitals Prescribing NINLARO | – | Other: No InterventionPharmacists 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Who belong to hospitals prescribing NINLARO.
- Who have instructed the dosing of NINLARO in IRD therapy to patients.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is a non-interventional study. | Other | Pharmacists in Hospitals Prescribing NINLARO |
Primary outcome
Number of Pharmacists Who Had Provided Patients With the Contents of the Risk Management Plan (RMP) Material
Time frame: 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.
3 secondary outcomes
Number of Pharmacists Who Had Received the RMP Material for Patients
Time frame: Up to Day 9
Number of Pharmacist With Understanding of the Proper NINLARO Dosing Schedule
Time frame: Up to Day 9
Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule
Time frame: Up to Day 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Takeda at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Pharmacists Who Had Provided Patients With the Contents of the Risk Management Plan (RMP) Material (time frame: Up to Day 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.