Ninlaro Intensive Drug Monitoring Protocol
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|ClinicalTrials.gov Identifier: NCT04328662|
Recruitment Status : Recruiting
First Posted : March 31, 2020
Last Update Posted : February 17, 2023
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|Condition or disease|
|Multiple Myeloma Neoplasms, Plasma Cell|
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 Type :||Observational|
|Estimated Enrollment :||3000 participants|
|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|
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.
- Number of Participants who Have one or More Adverse Events [ Time Frame: Up to Month 57 ]
- 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 ]
- Number of Participants With Dose Adjustments During the Study [ Time Frame: Up to Month 57 ]
- Number of Participants Categorized by Clinical Characteristics [ Time Frame: Up to Month 57 ]
- Number of Participants Based on Disease Characteristics [ Time Frame: Up to Month 57 ]
- Number of Participants With Multiple Myeloma Treatment [ Time Frame: Up to Month 57 ]
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|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|
1.Undergoing treatment with Ninlaro (of less than 3 months from initial treatment with Ninlaro) or to be prescribed with Ninlaro capsule.
1. Currently participates or plans to participate in any interventional clinical trial.
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
|Contact: Takeda Contact||1-877-825-3327||medinfoUS@takeda.com|
|Study Director:||Medical Director||Takeda|
|Other Study ID Numbers:||
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.|
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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases