Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205823
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-16
First Post:
2023-12-17
Brief Title:
Compare Clinical Outcomes Between Advanced Immunotherapy and Classical Immunochemotherapy in RRMM
Sponsor:
Seoul St Marys Hospital
Organization:
Seoul St Marys Hospital
Study Overview
Official Title:
A Retrospective Study to Compare Clinical Outcomes Between Advanced Immunotherapy and Classical Immunochemotherapy in Patients With RelapsedRefractory Multiple Myeloma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAREMM-2305
Brief Summary:
Purpose
This study aims to assess the efficacy of immunotherapeutic agents in real clinical settings by comparing the treatment outcomes of relapsedrefractory 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 Marys Hospital Yeouido St Marys Hospital Incheon St Marys Hospital and Eunpyeong St Marys Hospital from May 2009 to June 2023
- Selection Criteria
1 Patients diagnosed with multiple myeloma at Seoul St Marys Hospital Yeouido St Marys Hospital Incheon St Marys Hospital and Eunpyeong St Marys Hospital from May 2009 to June 2023
2 Age 19 and above
3 Patients who have undergone immunotherapy for the purpose of treating relapsedrefractory multiple myeloma
Immunotherapy is defined as one of the following drugs depending on the treatment timelineProteasome 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 14 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
This study aims to assess the efficacy of immunotherapeutic agents in real clinical settings by comparing the treatment outcomes of relapsedrefractory 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 Marys Hospital Yeouido St Marys Hospital Incheon St Marys Hospital and Eunpyeong St Marys Hospital from May 2009 to June 2023
- Selection Criteria
1 Patients diagnosed with multiple myeloma at Seoul St Marys Hospital Yeouido St Marys Hospital Incheon St Marys Hospital and Eunpyeong St Marys Hospital from May 2009 to June 2023
2 Age 19 and above
3 Patients who have undergone immunotherapy for the purpose of treating relapsedrefractory multiple myeloma
Immunotherapy is defined as one of the following drugs depending on the treatment timelineProteasome 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 14 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None