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Ninlaro Intensive Drug Monitoring Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04328662
Recruitment Status : Recruiting
First Posted : March 31, 2020
Last Update Posted : February 17, 2023
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Description
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Brief Summary:
The main purpose of this study is to evaluate the safety profile of ixazomib citrate (Ninlaro) to fulfill the regulatory authority's requirement of intensive drug monitoring (IDM) in Chinese population.

Condition or disease
Multiple Myeloma Neoplasms, Plasma Cell

Detailed Description:

This is a prospective, non-interventional study in Chinese participants with RRMM, NDMM and non-myeloma who are undergoing or will receive at least one dose of ixazomib citrate. Data will be collected to assess safety information used in the real world, based on known risks and missing safety information.

The study will enroll approximately 3000 participants. The data will be collected prospectively as part of routine clinical visits of participants. Participants will be assigned to one of the two observational cohorts:

  • Cohort 1: Participants with RRMM
  • Cohort 2: Participants with NDMM, RRMM, and Non-myeloma

The multi-center trial will be conducted in China. The overall duration of study will be approximately 57 months. All participants will be followed up for 21 months unless withdrawal of Informed Consent Form, lost or death, whichever comes first.

Study Design
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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A National, Prospective, Non-interventional Study of NINLARO in Real World Clinical Practice
Actual Study Start Date : May 18, 2020
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Cohort 1: Participants with RRMM
Participants diagnosed with relapsed or refractory multiple myeloma (RRMM) who have received at least one dose of ixazomib plus lenalidomide - low dose dexamethasone (IRd) treatment, will be observed prospectively. Data will be collected from study sites such as clinical departments and pharmacies in hospitals as a part of routine clinical visits of participants to evaluate effectiveness and safety information.
Cohort 2: Participants with NDMM, RRMM, and Non-myeloma
Participants with NDMM, RRMM, and Non-myeloma Participants diagnosed with newly diagnosed multiple myeloma (NDMM) who have received at least one dose of ixazomib-based regimen treatment and diagnosed with RRMM who have received at least one dose non-IRd ixazomib-based regimens treatment, and diagnosed with non-myeloma who have received at least one dose of ixazomib-based regimens treatment, will be observed prospectively. Data will be collected from study sites such as clinical departments and pharmacies in hospitals as a part of routine clinical visits of participants to evaluate effectiveness and safety information.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants who Have one or More Adverse Events [ Time Frame: Up to Month 57 ]

Secondary Outcome Measures :
  1. Number of Participants Reporting one or More Serious Adverse Events (SAEs), Adverse Drug Reaction (ADRs) and Adverse Events of Special Interest (AESI) [ Time Frame: Up to Month 57 ]
  2. Number of Participants With Dose Adjustments During the Study [ Time Frame: Up to Month 57 ]
  3. Number of Participants Categorized by Clinical Characteristics [ Time Frame: Up to Month 57 ]
  4. Number of Participants Based on Disease Characteristics [ Time Frame: Up to Month 57 ]
  5. Number of Participants With Multiple Myeloma Treatment [ Time Frame: Up to Month 57 ]
  6. Overall Survival (OS) [ Time Frame: From the date of sign Informed Consent Form to the date of death due to any cause (up to Month 57) ]
    OS is measured as the time from the date of sign Informed Consent Form to the date of death due to any cause.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese participants with RRMM who have received at least one dose of IRd or non-IRd ixazomib based regimen treatment, and NDMM and non-myeloma who have received at least one dose of ixazomib-based regimen treatment will be observed prospectively.
Criteria

Inclusion Criteria:

1.Undergoing treatment with Ninlaro (of less than 3 months from initial treatment with Ninlaro) or to be prescribed with Ninlaro capsule.

Exclusion Criteria:

1. Currently participates or plans to participate in any interventional clinical trial.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04328662


Contacts
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Contact: Takeda Contact 1-877-825-3327 medinfoUS@takeda.com

Locations
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Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Takeda
More Information
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT04328662    
Other Study ID Numbers: C16050
U1111-1237-5126 ( Registry Identifier: WHO )
EUPAS30733 ( Registry Identifier: ENCEPP )
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: February 17, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
URL: https://vivli.org/ourmember/takeda/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases