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Recruiting NCT06698887

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

— Observational Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Idecabtagene vicleucel.
Who it may be relevant to
Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Idecabtagene vicleucel
    As per CA089-1043 study protocol

Primary outcome measures

  • 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]
  • 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]
  • Persistent vector sequence monitoring [Time frame: Months 7-18 and annually from years 5-15]
Secondary outcome measures (6)
  • Progression-free survival (PFS) [Time frame: 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]
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 5 centers
  • Chonnam National University Hwasun Hospital — Hwasun
  • Seoul National University Hospital — Seoul
  • Asan Medical Center — Seoul
  • Samsung Medical Center — Seoul
  • The Catholic Univ. of Korea Seoul St. Mary's Hospital — Seoul

Identifiers

NCT: NCT06698887 · CA089-1081

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗