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

Bristol-Myers Squibb15 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Multiple Myeloma

Interventions

Idecabtagene vicleucelDRUG

As per CA089-1043 study protocol

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Chonnam National University Hwasun Hospital

Hwasun, Jeonranamdo, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

RECRUITING

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Outcomes

Primary Outcomes

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 Outcomes

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

Central 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

Data from ClinicalTrials.gov

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