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

Sung-Soo Park

Status

Enrolling

Conditions

Multiple Myeloma (MM)

Multiple Myeloma, Relapsed

Treatments

Drug: IMiD treatment

Drug: Antibody-Drug Conjugate

Drug: Monoclonal antibody

Drug: CAR-T Therapy

Drug: Proteasome Inhibitor

Drug: Bispecific antibody

Study type

Observational

Funder types

Other

Identifiers

NCT07051850

XC25OIDI0011

Details and patient eligibility

About

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.

Enrollment

174 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.