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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Idecabtagene vicleucel
  As per CA089-1043 study protocol

Первичные конечные точки

• Participant adverse events [Срок оценки: 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 [Срок оценки: At 4, 7, 13, and 25 months, and annually up to 15 years]
• Persistent vector sequence monitoring [Срок оценки: Months 7-18 and annually from years 5-15]

Вторичные конечные точки (6)

• Progression-free survival (PFS) [Срок оценки: Monthly up to 18 months and every two months after month 19 up to 15 years]
• Overall survival (OS) [Срок оценки: Every 3 months up to month 60, annually thereafter up to 15 years]
• Number of participants that achieve complete response or stringent complete response [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At months 4-18, every 2 months from months 19-59, and annually from years 5-15]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 5 центров

• 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

Идентификаторы

NCT: NCT06698887 · CA089-1081

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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