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

NCT07051850 | Recruiting DMC

• 1 other identifier: XC25OIDI0011
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma, Relapsed; Multiple Myeloma (MM)

Keywords

Relpased; Refractory; Advanced Immuno-Oncology Agents; Conventional Immunotherapies

Outcome Measures

Primary Outcomes (1)

• Quality of Lfe

  Quality of life is assessed using validated patient-reported outcome (PRO) questionnaires at baseline and regular intervals during treatment.

  From treatment initiation up to 12 months

Secondary Outcomes (1)

• Treatment Efficacy and Survival Outcomes

  From treatment initiation up to 12 months

Study Arms (2)

Advanced Immuno-oncology Therapy Group

Drug: Bispecific antibody; Drug: CAR-T Therapy

Conventional Immuno-oncology Therapy Group

Drug: Antibody-Drug Conjugate; Drug: Monoclonal antibody; Drug: Proteasome Inhibitor; Drug: IMiD treatment

Interventions

Bispecific antibody DRUG

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.

Advanced Immuno-oncology Therapy Group

Antibody-Drug Conjugate DRUG

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.

Conventional Immuno-oncology Therapy Group

Monoclonal antibody DRUG

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.

Conventional Immuno-oncology Therapy Group

Proteasome Inhibitor DRUG

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.

Conventional Immuno-oncology Therapy Group

IMiD treatment DRUG

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.

Conventional Immuno-oncology Therapy Group

CAR-T Therapy DRUG

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.

Advanced Immuno-oncology Therapy Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from Seoul St. Mary hospital and Yeoido St. Mary hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sung-Soo Park: lead
• Eunpyeong St. Mary's Hospital: collaborator

Study Sites (1)

Seoul St. Mary Hospital

Seocho, Seoul, 06591, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum, Bone marrow

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

Antibodies, Bispecific; Immunoconjugates; Antibodies, Monoclonal; Proteasome Inhibitors; Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Central Study Contacts

Sung-Soo Park, MD.PhD

CONTACT

+82-10-3782-2736; sspark@catholic.ac.kr

SeungHwan Shin, MD.PhD

CONTACT

+82-10-4604-6282; chironhmt@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: July 4, 2025
• Study Start: July 14, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)