Multiple MyelomaNCT06698887
A Study to Evaluate the Long-Term Safety of Idecabtagene Vicleucel Treatment in Adults With Newly Diagnosed Multiple Myeloma in Korea
An observational study of Multiple Myeloma, run by Bristol-Myers Squibb at 5 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Idecabtagene vicleucel
- How many people
- 15 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 11 Sep 2024to 27 Mar 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with newly diagnosed multiple myeloma (NDMM) who had a suboptimal response after autologous stem cell transplantation (ASCT) and who were treated with idecabtagene vicleucel in the KarMMa-9 (CA089-1043) Phase 3 clinical trial.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
First line of the email MUST contain NCT # and Site #. contact
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun, Jeonranamdo, 58128
Sung Hoon Jung, Site 0041, 82613797623
- Recruiting
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03080
SungSoo Yoon, Site 0039, 82-2-2072-3079
- Recruiting
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Dok Hyun Yoon, Site 0040, 82230105940
- Recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351
Kihyun Kim, Site 0038, +821099333456
- Recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 06591
Chang Ki Min, Site 0043, 82-20-2258-6053
About this study
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
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.
- Conditions
- Multiple Myeloma
- Being tested
- Idecabtagene vicleucel
- Keywords
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Idecabtagene vicleucelDrug
As per CA089-1043 study protocol
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving idecabtagene vicleucel | Not described Receives: Drug: Idecabtagene vicleucel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant adverse events
Measured: 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
Measured: At 4, 7, 13, and 25 months, and annually up to 15 years
Persistent vector sequence monitoring
Measured: Months 7-18 and annually from years 5-15
Secondary outcomes (6)
Progression-free survival (PFS)
Measured: Monthly up to 18 months and every two months after month 19 up to 15 years
Overall survival (OS)
Measured: Every 3 months up to month 60, annually thereafter up to 15 years
Number of participants that achieve complete response or stringent complete response
Measured: 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
Measured: 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
Measured: 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
Measured: At months 4-18, every 2 months from months 19-59, and annually from years 5-15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start11 Sep 2024
- Primary completion27 Mar 2031 (estimated)
- Study completion27 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698887
- Sponsor's protocol ID
- CA089-1081
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No