Multiple Myeloma
Conditions
Keywords
Multiple Myeloma
Brief summary
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
As per CA089-1043 study protocol
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant adverse events | 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 | At 4, 7, 13, and 25 months, and annually up to 15 years |
| Persistent vector sequence monitoring | Months 7-18 and annually from years 5-15 |
Secondary
| Measure | Time frame |
|---|---|
| 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 | At months 4-18, every 2 months from months 19-59, and annually from years 5-15 |
| Progression-free survival (PFS) | Monthly up to 18 months and every two months after month 19 up to 15 years |
| Health-related quality of life (HRQoL) measured by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire | 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 | At months 4-18, every 2 months from months 19-59, and annually from years 5-15 |
| Overall survival (OS) | Every 3 months up to month 60, annually thereafter up to 15 years |
| Number of participants that achieve complete response or stringent complete response | At months 4-18, every 2 months from months 19-59, and annually from years 5-15 |
Countries
South Korea
Contacts
Primary ContactBMS Study Connect Contact Center www.BMSStudyConnect.com
Backup ContactFirst line of the email MUST contain NCT # and Site #.
Outcome results
None listed