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Compare Clinical Outcomes Between Advanced Immunotherapy and Classical Immunochemotherapy in RRMM

A Retrospective Study to Compare Clinical Outcomes Between Advanced Immunotherapy and Classical Immunochemotherapy in Patients With Relapsed/Refractory Multiple Myeloma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06205823
Acronym
CAREMM-2305
Enrollment
1600
Registered
2024-01-16
Start date
2023-09-25
Completion date
2025-12-31
Last updated
2024-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myeloma Multiple

Brief 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. \[Primary Study Objective\] 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.

Interventions

DRUGImmunotherapy

Immunotherapy

Sponsors

Seoul St. Mary's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum

Inclusion 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of Survival Periods Among Groups Comparison of Survival Periods Among GroupsUp to 2 yearsoverall survival

Secondary

MeasureTime frameDescription
Comparison of Progression-Free Survival PeriodsUp to 2 yearsprogression-free survival
Comparison of Response RatesUp to 2 yearsresponse rate
Cost-effectiveness measured by incremental Cost-effectiveness ratio (ICER)Up to 2 yearscost-effectiveness ratio

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026