NCT06205823: CAREMM-2305

Compare Clinical Outcomes Between Advanced Immunotherapy and Classical Immunochemotherapy in RRMM

Status unknown Last updated 16 January 2024

What this trial tests

trial testing Immunotherapy in Myeloma Multiple in 1,600 participants. Status unknown.

Timeline

25 September 2023

Primary endpoint
31 December 2025

31 December 2025

Quick facts

Lead sponsor	Seoul St. Mary's Hospital
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	1,600
Start date	25 September 2023
Primary completion	31 December 2025
Estimated completion	31 December 2025
Sites	1 location across South Korea

Drugs / interventions tested

• Immunotherapy — full drug profile →

Conditions studied

• Myeloma Multiple — all drugs for Myeloma Multiple →

Sponsor

Seoul St. Mary's Hospital

Who can join

19 and older, any sex, with Myeloma Multiple. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

\[Purpose\]

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

1. 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.
2. Age 19 and above.
3. 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.
4. Exclusion Criteria:

Patients diagnosed with conditions other than monoclonal gammopathy of undetermined significance (MGUS) or multiple myeloma.
5. 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy and Safety of Bispecific T-Cell Engagers in Relapsed/Refractory Multiple Myeloma: A Real-World Data-Based Case-Controlled Study.
   Choi S, Byun JM, Park SS, Han J, et al · · 2025 · cited 3× · PMID 39608453 · DOI 10.1016/j.jtct.2024.11.010