NCT06205823

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. 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. 2.Age 19 and above.
  3. 3.Patients who have undergone immunotherapy\* for the purpose of treating relapsed/refractory multiple myeloma.
  4. 4.Exclusion Criteria:
  5. 5.Data Collection Period for Study Participants : April 1, 2009, to June 30, 2023.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

2.3 years

First QC Date

December 17, 2023

Last Update Submit

January 3, 2024

Conditions

Myeloma Multiple

Outcome Measures

Primary Outcomes (1)

  • Comparison of Survival Periods Among Groups Comparison of Survival Periods Among Groups

    overall survival

    Up to 2 years

Secondary Outcomes (3)

  • Comparison of Progression-Free Survival Periods

    Up to 2 years

  • Comparison of Response Rates

    Up to 2 years

  • Cost-effectiveness measured by incremental Cost-effectiveness ratio (ICER)

    Up to 2 years

Study Arms (2)

T cell engager

Drug: Immunotherapy

Standard-of-care

Drug: Immunotherapy

Interventions

ImmunotherapyDRUG

Immunotherapy

Standard-of-careT cell engager

Eligibility Criteria

Age19 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.
  • Age 19 and above.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 06591, South Korea

Location

Related Publications (1)

  • Choi S, Byun JM, Park SS, Han J, Oh S, Jung S, Park H, Han S, Lee JY, Koh Y, Jeon YW, Yahng SA, Shin SH, Yoon SS, Min CK. Efficacy and Safety of Bispecific T-Cell Engagers in Relapsed/Refractory Multiple Myeloma: A Real-World Data-Based Case-Controlled Study. Transplant Cell Ther. 2025 Feb;31(2):74.e1-74.e11. doi: 10.1016/j.jtct.2024.11.010. Epub 2024 Nov 26.

    PMID: 39608453DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Study Officials

  • Sung-Soo Park, Dr.

    Seoul

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 17, 2023

First Posted

January 16, 2024

Study Start

September 25, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 16, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)