Health TrialsbyHealthPanel

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

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Idecabtagene vicleucel

    Drug

    As per CA089-1043 study protocol

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Participants receiving idecabtagene vicleucel1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

Persistent vector sequence monitoring

Time frame
Months 7-18 and annually from years 5-15

Secondary outcomes

1

Progression-free survival (PFS)

Time frame
Monthly up to 18 months and every two months after month 19 up to 15 years
2

Overall survival (OS)

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

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov
Apply now