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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06698887
- Acronym / sponsor ID
- CA089-1081
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 27 Mar 2031 (estimated)
- Study completion
- 27 Mar 2031 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving idecabtagene vicleucel | – | Drug: Idecabtagene vicleucel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Idecabtagene vicleucelAs per CA089-1043 study protocol | Drug | Participants receiving idecabtagene vicleucel |
Primary outcome
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
6 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
Time frame: At months 4-18, every 2 months from months 19-59, and annually from years 5-15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Bristol-Myers Squibb at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.