Quality of Life and Treatment Outcomes in RRMM Patients Receiving Advanced vs. Conventional Immunotherapies

Recruiting

• Conditions: Multiple Myeloma, Relapsed; Multiple Myeloma (MM)
• Interventions: Drug: Bispecific antibody; Drug: Antibody-Drug Conjugate; Drug: CAR-T Therapy; Drug: Monoclonal antibody; Drug: Proteasome Inhibitor; Drug: IMiD treatment

• Registration Number: NCT07051850
• Lead Sponsor: Sung-Soo Park

Brief Summary

This is a non-interventional observational study aiming to evaluate the quality of life, efficacy, and safety of advanced immuno-oncology agents versus conventional immuno-oncology therapies in patients with relapsed or refractory multiple myeloma. A total of 174 participants are expected to be enrolled in this study.

The study consists of three parts:

Part 1 is the screening and enrollment phase, during which inclusion and exclusion criteria will be assessed for individuals who have agreed to participate in the study. Eligible participants will be enrolled, and data will be collected on their prioritized treatment value criteria.

Part 2 is the treatment phase, during which participants will receive either conventional immuno-oncology therapy or advanced immuno-oncology agents. Participants will visit the site on Day 1 of each treatment cycle to complete patient-reported outcomes (PROs), and efficacy and safety assessments will be conducted.

Part 3 is the end-of-study visit, during which PROs will again be collected, along with final efficacy and safety assessments.

Additionally, for exploratory purposes, bone marrow and peripheral blood samples will be collected from participants at Seoul St. Mary's Hospital who have consented to sample collection and provision during the study period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-09
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-02
• Study First Posted: 2025-07-04
• Last Update Submitted: 2025-07-10
• Study Start: 2025-07-14
• Last Update Posted: 2025-07-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

• Male or female aged 19 years or older.
• Diagnosed with multiple myeloma and have been previously treated with at least one proteasome inhibitor, one immunomodulatory drug, and one monoclonal antibody treatment (i.e., exposed to all three classes of immunotherapy agents).
• Diagnosed with relapsed or refractory multiple myeloma between the IRB approval date and December 2025, and scheduled to start treatment with either advanced immuno-oncology agents or conventional immuno-oncology agents within one month from screening.
• Provided written informed consent after receiving detailed explanation about the study and voluntarily agreed to participate and comply with study requirements.

Exclusion Criteria

• Those who do not agree to participate in the study.
• Patients diagnosed with plasma cell disorders other than multiple myeloma (e.g., lymphoma, POEMS syndrome).
• Individuals unable to read and understand documents written in Korean.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Advanced Immuno-oncology Therapy Group	Bispecific antibody	-
Advanced Immuno-oncology Therapy Group	CAR-T Therapy	-
Conventional Immuno-oncology Therapy Group	Proteasome Inhibitor	-
Conventional Immuno-oncology Therapy Group	Antibody-Drug Conjugate	-
Conventional Immuno-oncology Therapy Group	Monoclonal antibody	-
Conventional Immuno-oncology Therapy Group	IMiD treatment	-

Primary Outcome Measures

Name	Time	Method
Quality of Lfe	From treatment initiation up to 12 months	Quality of life is assessed using validated patient-reported outcome (PRO) questionnaires at baseline and regular intervals during treatment.

Secondary Outcome Measures

Name	Time	Method
Treatment Efficacy and Survival Outcomes	From treatment initiation up to 12 months	Treatment Efficacy will be assessed by objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). ORR will be reported as the percentage of participants with complete or partial response per IMWG criteria, based on clinical and imaging assessments. PFS and OS will be measured in months as time-to-event outcomes.; Survival Outcomes will be evaluated by the number of participants with adverse events (AEs) and serious adverse events (SAEs), graded using CTCAE. Laboratory safety will be assessed by the number of participants with CTCAE-defined lab abnormalities.

Trial Locations

Locations (1)

Seoul St. Mary Hospital; 🇰🇷 Seocho, Seoul, Korea, Republic of