A Study to Evaluate the Long-Term Safety of Idecabtagene Vicleucel Treatment in Adults With Newly Diagnosed Multiple Myeloma in Korea

Last updated: December 12, 2024
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer/tumors

Multiple Myeloma

Lymphoproliferative Disorders

Treatment

Idecabtagene vicleucel

Clinical Study ID

NCT06698887
CA089-1081
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to monitor the long-term safety of participants who received idecabtagene vicleucel treatment as part of the KarMMa-9 (CA089-1043) Phase 3 clinical trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult participants ≥19 years of age

  • Korean participants with newly diagnosed multiple myeloma who had a suboptimalresponse after autologous stem cell transplantation (ASCT) and who were treated withidecabtagene vicleucel (assigned to Arm A) in the KarMMa-9 trial (CA089-1043)

  • Participants must understand and voluntarily sign and informed consent form (ICF)for the Korea long-term follow-up surveillance study prior to anysurveillance-related procedures being conducted

Exclusion

Exclusion Criteria:

  • Participants who participate in KarMMa-9 trial (CA089-1043) but disagree withlong-term follow-up surveillance in Korea

  • Participants who are not possible to treat with Ide-cel within 9 dayspost-completion of lymphodepleting chemotherapy (LDC), if delays occur. However,depending on the participants recovery status, whether idecabtagene vicleucel isadministered or not, should be discussed with a medical monitor

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Idecabtagene vicleucel
Phase:
Study Start date:
September 11, 2024
Estimated Completion Date:
March 27, 2031

Connect with a study center

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeonranamdo 58128
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul] 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul] 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [Seoul] 03080
    Korea, Republic of

    Active - Recruiting

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    Seoul, Seoul-teukbyeolsi [Seoul] 06591
    Korea, Republic of

    Active - Recruiting

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