## Protocol Section
### Identification Module
**NCT ID:** NCT05882279

**Brief Title:** A Survey on NINLARO Risk Management Plan (RMP) Material Utilization Among Pharmacists in Japan

**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

#### Organization Study ID Info
**ID:** C16065
#### Organization
**Class:** INDUSTRY
**Full Name:** Takeda
### Status Module
#### Completion Date
**Date:** 2023-06-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-06-15

**Type:** ACTUAL

**Last Update Submit Date:** 2023-06-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-06-09

**Type:** ACTUAL

#### Start Date
**Date:** 2023-06-01

**Type:** ACTUAL

**Status Verified Date:** 2023-06

#### Study First Post Date
**Date:** 2023-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2023-05-22
**Study First Submit QC Date:** 2023-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Takeda

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Multiple Myeloma

**Keywords:**

- Drug Therapy

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 300

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: No Intervention

**Label:** Pharmacists in Hospitals Prescribing NINLARO

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Pharmacists in Hospitals Prescribing NINLARO

**Description:** This is a non-interventional study.

**Name:** No Intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Number of Pharmacists who Have Provided Patients With the Contents of the RMP Material

**Time Frame:** 12 days

#### Secondary Outcomes

**Measure:** Number of Pharmacists who Have Received the RMP Material for Patients

**Time Frame:** 12 days

**Measure:** Number of Pharmacist With Understanding of the Proper NINLARO Dosing Schedule

**Time Frame:** 12 days

**Measure:** Number of Pharmacist With Understanding of the Importance of Providing NINLARO Dosing Schedule

**Time Frame:** 12 days

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tokyo

**Country:** Japan

**Facility:** Takeda selected site

#### Overall Officials

**Official 1:**

**Affiliation:** Takeda

**Name:** Study Director

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Access Criteria:** 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.

**Description:** 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.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

**IPD Sharing:** YES

**URL:** https://vivli.org/ourmember/takeda/

### References Module

#### See Also Links

**Label:** To obtain more information on the study, click here/on this link

**URL:** https://clinicaltrials.takeda.com/study-detail/b6e2fa0988884fc1

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000054219

- Term: Neoplasms, Plasma Cell

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000020141

- Term: Hemostatic Disorders

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010265

- Term: Paraproteinemias

- ID: D000001796

- Term: Blood Protein Disorders

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000006474

- Term: Hemorrhagic Disorders

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12058

- Name: Multiple Myeloma

- Relevance: HIGH

- As Found: Multiple Myeloma

- ID: M27588

- Name: Neoplasms, Plasma Cell

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M21977

- Name: Hemostatic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5059

- Name: Blood Coagulation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13178

- Name: Paraproteinemias

- Relevance: LOW

- As Found: Unknown

- ID: M5077

- Name: Blood Protein Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9560

- Name: Hemorrhagic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3947

- Name: Multiple Myeloma

- Relevance: HIGH

- As Found: Multiple Myeloma

### Condition Browse Module - Meshes

- ID: D000009101

- Term: Multiple Myeloma

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M238820

- Name: Ixazomib

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2024-05-23

##### Submission Infos

- MCP Release N: Unknown

- Release Date: 2024-05-23

- Reset Date: Unknown

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-24
