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

NCT06698887 | Recruiting FDA Drug

• 1 other identifier: CA089-1081
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

• Participant adverse events

  Monthly from months 4-18, every 2 months from months 19-59, and annually from month year 5 to 15

• Number of participants with positive replication-competent lentivirus test results

  At 4, 7, 13, and 25 months, and annually up to 15 years

• Persistent vector sequence monitoring

  Months 7-18 and annually from years 5-15

Secondary Outcomes (6)

• Progression-free survival (PFS)

  Monthly up to 18 months and every two months after month 19 up to 15 years

• Overall survival (OS)

  Every 3 months up to month 60, annually thereafter up to 15 years

• Number of participants that achieve complete response or stringent complete response

  At months 4-18, every 2 months from months 19-59, and annually from years 5-15

• Health-related quality of life (HRQoL) measured by the European Organization for Research and Treatment of Cancer core quality of life (EORTC QLQ-C30) questionnaire

  At months 4-18, every 2 months from months 19-59, and annually from years 5-15

• Health-related quality of life (HRQoL) measured by the European Organization for Research and Treatment of Cancer assessment of quality of life of myeloma patients (EORTC QLQ-MY20) questionnaire

  At months 4-18, every 2 months from months 19-59, and annually from years 5-15

Study Arms (1)

Participants receiving idecabtagene vicleucel

Drug: Idecabtagene vicleucel

Interventions

Idecabtagene vicleucel DRUG

As per CA089-1043 study protocol

Participants receiving idecabtagene vicleucel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with newly diagnosed multiple myeloma (NDMM) who had a suboptimal response after autologous stem cell transplantation (ASCT) and who were treated with idecabtagene vicleucel in the KarMMa-9 (CA089-1043) Phase 3 clinical trial.

You may qualify if:

• Adult participants ≥19 years of age
• Korean participants with newly diagnosed multiple myeloma who had a suboptimal response after autologous stem cell transplantation (ASCT) and who were treated with idecabtagene 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 any surveillance-related procedures being conducted

You may not qualify if:

• Participants who participate in KarMMa-9 trial (CA089-1043) but disagree with long-term follow-up surveillance in Korea
• Participants who are not possible to treat with Ide-cel within 9 days post-completion of lymphodepleting chemotherapy (LDC), if delays occur. However, depending on the participants recovery status, whether idecabtagene vicleucel is administered or not, should be discussed with a medical monitor

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (5)

Chonnam National University Hwasun Hospital

Hwasun, Jeonranamdo, 58128, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea

RECRUITING

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

RECRUITING

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

Seoul, Seoul-teukbyeolsi [Seoul], 06591, South Korea

RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Multiple Myeloma

Interventions

idecabtagene vicleucel

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: September 11, 2024
• Primary Completion (Estimated): March 27, 2031
• Study Completion (Estimated): March 27, 2031
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)