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

December 12, 2024 updated by: Bristol-Myers Squibb

Long-Term Safety Follow-Up Surveillance for Phase 3 Trial (KarMMA-9/CA089-1043) to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

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

Study Locations

  • Korea, Republic of
    • Jeonranamdo
      • Hwasun, Jeonranamdo, Korea, Republic of, 58128
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Contact:
          • Sung Hoon Jung, Site 0041
          • Phone Number: 82613797623
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Dok Hyun Yoon, Site 0040
          • Phone Number: 82230105940
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Kihyun Kim, Site 0038
          • Phone Number: +821099333456
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • SungSoo Yoon, Site 0039
          • Phone Number: 82-2-2072-3079
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06591
        • Recruiting
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital
        • Contact:
          • Chang Ki Min, Site 0043
          • Phone Number: 82-20-2258-6053

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants receiving idecabtagene vicleucel
Drug: Idecabtagene vicleucel
As per CA089-1043 study protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Participant adverse events
Time Frame: Monthly from months 4-18, every 2 months from months 19-59, and annually from month year 5 to 15
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
Time Frame: At 4, 7, 13, and 25 months, and annually up to 15 years
At 4, 7, 13, and 25 months, and annually up to 15 years
Persistent vector sequence monitoring
Time Frame: Months 7-18 and annually from years 5-15
Months 7-18 and annually from years 5-15

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: Monthly up to 18 months and every two months after month 19 up to 15 years
Monthly up to 18 months and every two months after month 19 up to 15 years
Overall survival (OS)
Time Frame: Every 3 months up to month 60, annually thereafter up to 15 years
Every 3 months up to month 60, annually thereafter up to 15 years
Number of participants that achieve complete response or stringent complete response
Time Frame: At months 4-18, every 2 months from months 19-59, and annually from years 5-15
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
Time Frame: At months 4-18, every 2 months from months 19-59, and annually from years 5-15
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
Time Frame: At months 4-18, every 2 months from months 19-59, and annually from years 5-15
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 EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire
Time Frame: At months 4-18, every 2 months from months 19-59, and annually from years 5-15
At months 4-18, every 2 months from months 19-59, and annually from years 5-15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2024

Primary Completion (Estimated)

March 27, 2031

Study Completion (Estimated)

March 27, 2031

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Actual)

November 21, 2024

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA089-1081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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