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Completed

NCT Number: NCT04328662

A Study of Ninlaro in Real World Clinical Practice in China

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.

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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

Anhui Cancer Hospital, Hefei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Number of Participants who Have one or More Adverse Events

    Time frame: From signing of the informed consent to 60 days after administration of the last dose of NINLARO (Up to Month 64)

Secondary outcomes

  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: From signing of the informed consent to 60 days after administration of the last dose of NINLARO (Up to Month 64)

  2. Number of Participants With Dose Adjustments During the Study

    Time frame: Up to Month 64

  3. Number of Participants Categorized by Clinical Characteristics

    Time frame: Up to Month 64

  4. Number of Participants Based on Disease Characteristics

    Time frame: Up to Month 64

  5. Number of Participants With Multiple Myeloma Treatment

    Time frame: Up to Month 64

  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 64)

    OS is measured as the time from the date of sign Informed Consent Form to the date of death due to any cause.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2020
Registry last updated
Mar 4, 2026

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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