Monitoring long-term safety of idecabtagene vicleucel in newly diagnosed multiple myeloma patients in Korea
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
This study is testing the long-term safety of a treatment called idecabtagene vicleucel in adults with newly diagnosed multiple myeloma who didn't respond well after their stem cell transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Hwasun, Jeonranamdo and 4 other locations) |
| Trial ID | NCT06698887 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the long-term safety of idecabtagene vicleucel treatment in adults with newly diagnosed multiple myeloma who previously participated in the KarMMa-9 clinical trial. Participants will be monitored for safety outcomes following their treatment. The study focuses on individuals who had a suboptimal response after autologous stem cell transplantation. It is an observational study that will collect data on the long-term effects of the treatment.
Who should consider this trial
Good fit: Ideal candidates include Korean adults aged 19 and older with newly diagnosed multiple myeloma who had a suboptimal response after autologous stem cell transplantation and received idecabtagene vicleucel.
Not a fit: Patients who do not agree to long-term follow-up surveillance or who are unable to receive idecabtagene vicleucel within the specified timeframe may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety profile of idecabtagene vicleucel, potentially improving treatment strategies for multiple myeloma.
How similar studies have performed: While this study builds on previous findings from the KarMMa-9 trial, the long-term safety evaluation of idecabtagene vicleucel in this specific population is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hwasun, Jeonranamdo and 4 other locations
- 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 (Recruiting)
- Samsung Medical Center — Seoul, Seoul-teukbyeolsi [Seoul], South Korea (Recruiting)
- The Catholic Univ. of Korea Seoul St. Mary's Hospital — Seoul, Seoul-teukbyeolsi [Seoul], South Korea (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.