A Study of Real-World Use of Ixazomib Citrate in People With Multiple Myeloma (MM)

Last updated: July 22, 2024
Sponsor: Takeda
Overall Status: Completed

Phase

N/A

Condition

Bone Neoplasm

Leukemia

Lymphoproliferative Disorders

Treatment

No Intervention

Clinical Study ID

NCT04840680
C16030
  • All Genders

Study Summary

In this study, people with MM will be treated with ixazomib citrate according to their clinic's standard practice. The main aim of the study is to check for side effects from ixazomib citrate.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants with MM.

  2. Participants who are prescribed and initiate ixazomib citrate for the treatment ofMM according to the ixazomib citrate South Korean product label.

Exclusion

Exclusion Criteria:

  1. Participants treated with ixazomib citrate outside of the locally approved label inSouth Korea.

  2. Participants for which ixazomib citrate is contraindicated as per product label.

Study Design

Total Participants: 191
Treatment Group(s): 1
Primary Treatment: No Intervention
Phase:
Study Start date:
March 22, 2021
Estimated Completion Date:
August 28, 2023

Study Description

This is a non-interventional, prospective, observational post-marketing surveillance study of ixazomib citrate in participants with MM.

The study will assess the safety and effectiveness of ixazomib citrate for its approved indications in a clinical practice setting under real-world conditions.

The study will enroll approximately 165 participants. The data will be prospectively collected, at the centers from medical files and recorded into electronic case report forms (e-CRFs).

All participants will be enrolled in a single observational group:

• Participants With MM

The study will be conducted in South Korea. The overall duration of the study will be approximately 6 years and 11 months. Data will be collected over and up to a 6 months-surveillance period (per participant) once enrolled.

Connect with a study center

  • empty

    Hwasun-gun, Jeollanam-do
    Korea, Republic of

    Site Not Available

  • Hallym University Sacred Heart Hospital

    Anyang, 14068
    Korea, Republic of

    Site Not Available

  • SOONCHUNHYANG UNIVERSITY HOSPITAL Bucheon

    Bucheon, 14584
    Korea, Republic of

    Site Not Available

  • Inje University Busan Paik Hospital

    Busan, 47392
    Korea, Republic of

    Site Not Available

  • Kosin University Gospel Hospital

    Busan, 49267
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital

    Busan, 49241
    Korea, Republic of

    Site Not Available

  • Keimyung University Dongsan Hospital

    Daegu, 42601
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Hospital

    Daegu, 41944
    Korea, Republic of

    Site Not Available

  • Chungnam National Unversity Hospital

    Daejeon, 35015
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Hwasun, 58128
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Incheon ST. Marys Hospital

    Incheon, 21431
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Hospital

    Seoul, 06973
    Korea, Republic of

    Site Not Available

  • Ewha womans university medical center

    Seoul, 07985
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital

    Seoul, 02841
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul, 08308
    Korea, Republic of

    Site Not Available

  • Samsung medical center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea Seoul ST. Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon, 16499
    Korea, Republic of

    Site Not Available

  • Yonsei University Wonju Severance Christian Hospital

    Wonju, 26426
    Korea, Republic of

    Site Not Available

  • Yongin Severance Hospital

    Yongin, 16995
    Korea, Republic of

    Site Not Available

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