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NCT Number: NCT05882279

A Survey on NINLARO Risk Management Plan (RMP) Material Utilization Among Pharmacists 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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda selected site

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Who belong to hospitals prescribing NINLARO.
  • Who have instructed the dosing of NINLARO in IRD therapy to patients.

Exclusion criteria

None

Treatment and study plan

No intervention

Other

This is a non-interventional study.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of Pharmacists Who Had Received the RMP Material for Patients

    Time frame: 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.

  2. Number of Pharmacist With Understanding of the Proper NINLARO Dosing Schedule

    Time frame: 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.

  3. Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 31, 2023
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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