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

NCT07051850 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 174

Last updated 2025-07-15

No results posted yet for this study

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.

Conditions

  • Multiple Myeloma, Relapsed
  • Multiple Myeloma (MM)

Interventions

DRUG

Bispecific antibody

It uses a dual targeting mechanism to enhance specificity and immune activation. It is an off-the-shelf treatment, and doesn't require a manufacturing process of patient cells.

DRUG

Antibody-Drug Conjugate

It is a targeted therapy consisting of a monoclonal antibody linked to a cytotoxic drug. The antibody binds to a specific antigen on cancer cells, delivering the cytotoxic agent directly to the tumor, minimizing systemic toxicity.

DRUG

Monoclonal antibody

Monoclonal antibodies are lab-engineered antibodies that target specific antigens expressed on cancer cells. These commonly target CD20 (rituximab or obinutuzumab) to mediate immune destruction.

DRUG

Proteasome Inhibitor

It blocks the activity of proteasomes, which role is degrading damaged proteins. This disruption induces apoptosis in cancer cells. Common agents include bortezomib and carfilzomib.

DRUG

IMiD treatment

Immune modulatory drugs modulate the immune response by enhancing T-cell and NK cell activty to disrupt tumor progression. Common drugs include lenalidomide and thalidomide.

DRUG

CAR-T Therapy

It uses the patient's own T cells, and requires a manufacturing process to modify and expand T cells before infusion. It directly targets B cell specific antigens, such as CD19 or CD20.

Sponsors & Collaborators

  • Eunpyeong St. Mary's Hospital

    collaborator OTHER

  • Sung-Soo Park

    lead OTHER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-14
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07051850 on ClinicalTrials.gov