Compare Clinical Outcomes Between Advanced Immunotherapy and Classical Immunochemotherapy in RRMM (CAREMM-2305)

January 3, 2024 updated by: Sung-Soo Park, Seoul St. Mary's Hospital

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.

[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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06591
        • Seoul St. Mary's Hospital, The Catholic University of Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
T cell engager
Drug: Immunotherapy
Immunotherapy
Standard-of-care
Drug: Immunotherapy
Immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Survival Periods Among Groups Comparison of Survival Periods Among Groups
Time Frame: Up to 2 years
overall survival
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Progression-Free Survival Periods
Time Frame: Up to 2 years
progression-free survival
Up to 2 years
Comparison of Response Rates
Time Frame: Up to 2 years
response rate
Up to 2 years
Cost-effectiveness measured by incremental Cost-effectiveness ratio (ICER)
Time Frame: Up to 2 years
cost-effectiveness ratio
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul St. Mary's Hospital

Investigators

  • Study Director: Sung-Soo Park, Dr., Seoul

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 17, 2023

First Submitted That Met QC Criteria

January 3, 2024

First Posted (Actual)

January 16, 2024

Study Record Updates

Last Update Posted (Actual)

January 16, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XC23RIDI0066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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