Myeloma MultipleCAREMM-2305NCT06205823
Compare Clinical Outcomes Between Advanced Immunotherapy and Classical Immunochemotherapy in RRMM
An observational study of Myeloma Multiple, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
[Purpose] This study aims to assess the efficacy of immunotherapeutic agents in real clinical settings by comparing the treatment outcomes of relapsed/refractory multiple myeloma patients treated with immunotherapeutic agents and classical immunotherapeutic agents. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Myeloma Multiple
- What is being tested?
- Immunotherapy
- How many people
- 1,600 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Sep 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with plasma cell disorders (PCD) at Seoul St. Mary's Hospital, Yeouido St. Mary's Hospital, Incheon St. Mary's Hospital, and Eunpyeong St. Mary's Hospital from May 2009 to June 2023.
Who may be able to join
- Patients diagnosed with multiple myeloma at Seoul St. Mary's Hospital, Yeouido St. Mary's Hospital, Incheon St. Mary's Hospital, and Eunpyeong St. Mary's Hospital from May 2009 to June 2023.
- Age 19 and above.
- Patients who have undergone immunotherapy* for the purpose of treating relapsed/refractory multiple myeloma.
- Immunotherapy is defined as one of the following drugs depending on the treatment timeline:
- Proteasome inhibitor, immune modulatory drug, monoclonal antibody, Chimeric Antigen Receptor T-cell therapy (CAR-T), bispecific antibody, antibody-drug conjugate.
Who cannot join
- Patients diagnosed with conditions other than monoclonal gammopathy of undetermined significance (MGUS) or multiple myeloma.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, 06591
About this study
Official title: A Retrospective Study to Compare Clinical Outcomes Between Advanced Immunotherapy and Classical Immunochemotherapy in Patients With Relapsed/Refractory Multiple Myeloma
[Purpose]
This study aims to assess the efficacy of immunotherapeutic agents in real clinical settings by comparing the treatment outcomes of relapsed/refractory multiple myeloma patients treated with immunotherapeutic agents and classical immunotherapeutic agents.
Read more
[Primary Study Objective] Compare the overall survival duration among patients based on the administered treatments.
[Secondary Study Objectives] Compare the progression-free survival duration among patients based on the administered treatments.
Compare the response rates among patients based on the administered treatments. Compare the healthcare costs associated with the administered treatments among patients.
[Study Participants]
Patients diagnosed with plasma cell disorders (PCD) at Seoul St. Mary's Hospital, Yeouido St. Mary's Hospital, Incheon St. Mary's Hospital, and Eunpyeong St. Mary's Hospital from May 2009 to June 2023.
- Selection Criteria
- Patients diagnosed with multiple myeloma at Seoul St. Mary's Hospital, Yeouido St. Mary's Hospital, Incheon St. Mary's Hospital, and Eunpyeong St. Mary's Hospital from May 2009 to June 2023.
- Age 19 and above.
- Patients who have undergone immunotherapy* for the purpose of treating relapsed/refractory multiple myeloma. *Immunotherapy is defined as one of the following drugs depending on the treatment timeline:Proteasome inhibitor, immune modulatory drug, monoclonal antibody, Chimeric Antigen Receptor T-cell therapy (CAR-T), bispecific antibody, antibody-drug conjugate.
- Exclusion Criteria: Patients diagnosed with conditions other than monoclonal gammopathy of undetermined significance (MGUS) or multiple myeloma.
- Data Collection Period for Study Participants : April 1, 2009, to June 30, 2023.
[ Study plan] This study is a cross-sectional study that includes all patients who meet the selection criteria for a specific period.
All participants meeting the selection criteria are included in the study and investigated for the items.
Among the study participants, patients who received immunotherapy agents defined as immune checkpoint inhibitors are identified as the experimental group.
The entire cohort is initially defined as the control group for the experimental group.
From the initial control group, a final control group is determined by matching with the experimental group based on specific variables, including treatment cycles, in a 1:4 ratio. However, the cohort size for matching can be adjusted during the study. Comparative analyses are conducted between the experimental and control groups, examining baseline variables and outcome variables.
- Conditions
- Myeloma Multiple
- Being tested
- Immunotherapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunotherapyDrug
Immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| T cell engager | Not described Receives: Drug: Immunotherapy | |
| Standard-of-care | Not described Receives: Drug: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Survival Periods Among Groups Comparison of Survival Periods Among Groups
overall survival
Measured: Up to 2 years
Secondary outcomes (3)
Comparison of Progression-Free Survival Periods
progression-free survival
Measured: Up to 2 years
Comparison of Response Rates
response rate
Measured: Up to 2 years
Cost-effectiveness measured by incremental Cost-effectiveness ratio (ICER)
cost-effectiveness ratio
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start25 Sep 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myeloma MultipleStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung-Soo Park, Seoul St. Mary's Hospital
- Investigators
- Sung-Soo Park, Dr., Study director, Seoul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205823
- Sponsor's protocol ID
- XC23RIDI0066
- Acronym
- CAREMM-2305
- Status last verified
- Jan 2024
- First submitted
- 17 Dec 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi S, Byun JM, Park SS, Han J, Oh S, Jung S, Park H, Han S, Lee JY, Koh Y, Jeon YW, Yahng SA, Shin SH, Yoon SS, Min CK. Efficacy and Safety of Bispecific T-Cell Engagers in Relapsed/Refractory Multiple Myeloma: A Real-World Data-Based Case-Controlled Study. Transplant Cell Ther. 2025 Feb;31(2):74.e1-74.e11. doi: 10.1016/j.jtct.2024.11.010. Epub 2024 Nov 26.
PubMed 39608453
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Compare Clinical Outcomes Between Advanced Immunotherapy and Classical Immunochemotherapy in Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06205823
- Acronym / sponsor ID
- CAREMM-2305 / XC23RIDI0066
- Conditions
- Myeloma Multiple
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Jan 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.
[Purpose]
This study aims to assess the efficacy of immunotherapeutic agents in real clinical settings by comparing the treatment outcomes of relapsed/refractory multiple myeloma patients treated with immunotherapeutic agents and classical immunotherapeutic agents.
[Primary Study Objective] Compare the overall survival duration among patients based on the administered treatments.
[Secondary Study Objectives] Compare the progression-free survival duration among patients based on the administered treatments.
Compare the response rates among patients based on the administered treatments. Compare the healthcare costs associated with the administered treatments among patients.
[Study Participants]
Patients diagnosed with plasma cell disorders (PCD) at Seoul St. Mary's Hospital, Yeouido St. Mary's Hospital, Incheon St. Mary's Hospital, and Eunpyeong St. Mary's Hospital from May 2009 to June 2023.
- Selection Criteria
- Patients diagnosed with multiple myeloma at Seoul St. Mary's Hospital, Yeouido St. Mary's Hospital, Incheon St. Mary's Hospital, and Eunpyeong St. Mary's Hospital from May 2009 to June 2023.
- Age 19 and above.
- Patients who have undergone immunotherapy* for the purpose of treating relapsed/refractory multiple myeloma. *Immunotherapy is defined as one of the following drugs depending on the treatment timeline:Proteasome inhibitor, immune modulatory drug, monoclonal antibody, Chimeric Antigen Receptor T-cell therapy (CAR-T), bispecific antibody, antibody-drug conjugate.
- Exclusion Criteria: Patients diagnosed with conditions other than monoclonal gammopathy of undetermined significance (MGUS) or multiple myeloma.
- Data Collection Period for Study Participants : April 1, 2009, to June 30, 2023.
[ Study plan] This study is a cross-sectional study that includes all patients who meet the selection criteria for a specific period.
All participants meeting the selection criteria are included in the study and investigated for the items.
Among the study participants, patients who received immunotherapy agents defined as immune checkpoint inhibitors are identified as the experimental group.
The entire cohort is initially defined as the control group for the experimental group.
From the initial control group, a final control group is determined by matching with the experimental group based on specific variables, including treatment cycles, in a 1:4 ratio. However, the cohort size for matching can be adjusted during the study. Comparative analyses are conducted between the experimental and control groups, examining baseline variables and outcome variables.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T cell engager | – | Drug: Immunotherapy |
| Standard-of-care | – | Drug: Immunotherapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with plasma cell disorders (PCD) at Seoul St. Mary's Hospital, Yeouido St. Mary's Hospital, Incheon St. Mary's Hospital, and Eunpyeong St. Mary's Hospital from May 2009 to June 2023.
Key inclusion criteria (5 listed)
- Patients diagnosed with multiple myeloma at Seoul St. Mary's Hospital, Yeouido St. Mary's Hospital, Incheon St. Mary's Hospital, and Eunpyeong St. Mary's Hospital from May 2009 to June 2023.
- Age 19 and above.
- Patients who have undergone immunotherapy* for the purpose of treating relapsed/refractory multiple myeloma.
- Proteasome inhibitor, immune modulatory drug, monoclonal antibody, Chimeric Antigen Receptor T-cell therapy (CAR-T), bispecific antibody, antibody-drug conjugate.
Key exclusion criteria (1 listed)
- Patients diagnosed with conditions other than monoclonal gammopathy of undetermined significance (MGUS) or multiple myeloma.
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 |
|---|---|---|
| ImmunotherapyImmunotherapy | Drug | Standard-of-care, T cell engager |
Primary outcome
Comparison of Survival Periods Among Groups Comparison of Survival Periods Among Groups
Time frame: Up to 2 years
overall survival
3 secondary outcomes
Comparison of Progression-Free Survival Periods
Time frame: Up to 2 years
Comparison of Response Rates
Time frame: Up to 2 years
Cost-effectiveness measured by incremental Cost-effectiveness ratio (ICER)
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Derived from this study: PubMed 39608453Choi S, Byun JM, Park SS, Han J, Oh S, Jung S, Park H, Han S, Lee JY, Koh Y, Jeon YW, Yahng SA, Shin SH, Yoon SS, Min CK. Efficacy and Safety of Bispecific T-Cell Engagers in Relapsed/Refractory Multiple Myeloma: A Real-World Data-Based Case-Controlled Study. Transplant Cell Ther. 2025 Feb;31(2):74.e1-74.e11. doi: 10.1016/j.jtct.2024.11.010. Epub 2024 Nov 26.
- Individual participant dataSharing planned: No
Related trials for Myeloma Multiple
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Not yet recruitingPhase 3
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Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
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Multiple Myeloma (MM)
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. This study is not recruiting at the moment.
Sung-Soo Park, Dr. study director
Seoul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloma Multiple, run by Seoul St. Mary's Hospital at 1 site 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Survival Periods Among Groups Comparison of Survival Periods Among Groups (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06205823, which also lists 1 linked publication.
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 16 Jan 2024.