Compare Clinical Outcomes Between Advanced Immunotherapy and Classical Immunochemotherapy in RRMM

Myeloma Multiple Clinical Trial

— CAREMM-2305  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06205823
• Other study ID #: XC23RIDI0066
• Status: Active, not recruiting
• Start date: September 25, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

[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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1600
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma Multiple
• Neoplasms, Plasma Cell

Intervention

Drug:
• Immunotherapy
Immunotherapy

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital, The Catholic University of Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Survival Periods Among Groups Comparison of Survival Periods Among Groups	overall survival	Up to 2 years
Secondary	Comparison of Progression-Free Survival Periods	progression-free survival	Up to 2 years
Secondary	Comparison of Response Rates	response rate	Up to 2 years
Secondary	Cost-effectiveness measured by incremental Cost-effectiveness ratio (ICER)	cost-effectiveness ratio	Up to 2 years