A Study of Ninlaro in Real World Clinical Practice in China

Study Overview
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Brief Summary
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The main purpose of this study is to collect additional safety information of ixazomib citrate (Ninlaro) when used to treat multiple myeloma in real world clinical practice in China. Participants will be treated with Ninlaro according to the normal clinical practice during this study.

Detailed Description
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This is a prospective, non-interventional study in Chinese participants with relapsed refractory multiple myeloma (RRMM), newly diagnosed multiple myeloma (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 when NINLARO is used in the real world, based on known risks and missing safety information. The study will enroll approximately 3000 patients. 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 64 months. All participants will be followed up for 21 months unless withdrawal of Informed Consent Form, loss of follow-up or death, whichever comes first.

Official Title
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A National, Prospective, Non-interventional Study of NINLARO in Real World Clinical Practice

Conditions
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Multiple Myeloma, Neoplasms, Plasma Cell

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing treatment with Ninlaro (of less than 3 months from initial treatment with Ninlaro) or to be prescribed with Ninlaro capsule. Participants will be able to sign Informed Consent Form to participate. Exclusion Criteria: Currently participates or plans to participate in any interventional clinical trial. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1: Participants with RRMM<br>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<br>Participants diagnosed with NDMM who have received at least one dose of ixazomib-based regimen treatment, 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who Have one or More Adverse Events |  | From signing of the informed consent to 60 days after administration of the last dose of NINLARO (Up to Month 64) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting one or More Serious Adverse Events (SAEs), Adverse Drug Reaction (ADRs) and Adverse Events of Special Interest (AESI) |  | From signing of the informed consent to 60 days after administration of the last dose of NINLARO (Up to Month 64) | 
| Number of Participants With Dose Adjustments During the Study |  | Up to Month 64 | 
| Number of Participants Categorized by Clinical Characteristics |  | Up to Month 64 | 
| Number of Participants Based on Disease Characteristics |  | Up to Month 64 | 
| Number of Participants With Multiple Myeloma Treatment |  | Up to Month 64 | 
| Overall Survival (OS) | OS is measured as the time from the date of sign Informed Consent Form to the date of death due to any cause. | From the date of sign Informed Consent Form to the date of death due to any cause (Up to Month 64) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy