NCT Number: NCT07051850
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.
Interested in participating?
Request Info19 year and older
All sexes
Observational
Seocho, Seoul, 06591, South Korea
Location status: Recruiting
Chang-Ki Min, MD.PhD
SUB_INVESTIGATOR
SeungHwan Shin, MD.PhD
CONTACT
SeungHwan Shin, MD.PhD
SUB_INVESTIGATOR
Sung-Soo Park, MD.PhD
CONTACT
Sung-Soo Park, MD.PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
SeungHwan Shin, MD.PhD
CONTACT
Sung-Soo Park, MD.PhD
CONTACT
Sung-Soo Park
Other
Observational Study of Quality of Life, Efficacy, and Safety Following Administration of Advanced Immuno-Oncology Agents Versus Conventional Immunotherapies in Patients With Relapsed/Refractory Multiple Myeloma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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