Multiple Myeloma, RelapsedNCT07051850
Quality of Life and Treatment Outcomes in RRMM Patients Receiving Advanced vs. Conventional Immunotherapies
An observational study of Multiple Myeloma, Relapsed and Multiple Myeloma (MM), run by Sung-Soo Park at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Multiple Myeloma, Relapsed, Multiple Myeloma (MM)
- What is being tested?
- Bispecific antibody, Antibody-Drug Conjugate and Monoclonal antibody
- Type of treatment
- Injection or infusion
- How many people
- 174 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jul 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be selected from Seoul St. Mary hospital and Yeoido St. Mary hospital
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St. Mary Hospital
Seocho, Seoul, 06591
Sung-Soo Park, MD.PhD, +82-10-3782-2736, sspark@catholic.ac.kr
SeungHwan Shin, MD.PhD, +82-10-4604-6282, chironhmt@gmail.com
About this study
Official title: 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
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:
Read more
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)
- Being tested
- Bispecific antibody, Antibody-Drug Conjugate, Monoclonal antibody, Proteasome Inhibitor, IMiD treatment
- Keywords
- Relpased, Refractory, Advanced Immuno-Oncology Agents, Conventional Immunotherapies
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispecific antibodyDrug
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.
Antibody-Drug ConjugateDrug
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 antibodyDrug
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.
Proteasome InhibitorDrug
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.
IMiD treatmentDrug
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.
CAR-T TherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Immuno-oncology Therapy Group | Not described Receives: Drug: Bispecific antibody; Drug: CAR-T Therapy | |
| Conventional Immuno-oncology Therapy Group | Not described Receives: Drug: Antibody-Drug Conjugate; Drug: Monoclonal antibody; Drug: Proteasome Inhibitor; Drug: IMiD treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Lfe
Quality of life is assessed using validated patient-reported outcome (PRO) questionnaires at baseline and regular intervals during treatment.
Measured: From treatment initiation up to 12 months
Secondary outcomes (1)
Treatment Efficacy and Survival Outcomes
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.
Measured: From treatment initiation up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start14 Jul 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma, RelapsedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sung-Soo Park
- Sponsor type
- University, hospital or other
- Collaborators
- Eunpyeong St. Mary's Hospital
- Responsible party
- Sponsor-investigator, Sung-Soo Park, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051850
- Sponsor's protocol ID
- XC25OIDI0011
- Status last verified
- Jul 2025
- First submitted
- 9 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07051850
- Acronym / sponsor ID
- XC25OIDI0011
- Conditions
- Multiple Myeloma, Relapsed, Multiple Myeloma (MM)
- Keywords
- Relpased, Refractory, Advanced Immuno-Oncology Agents, Conventional Immunotherapies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Sung-Soo ParkUniversity, hospital or other
- Collaborators
- Eunpyeong St. Mary's Hospital
- Study start
- 14 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected from Seoul St. Mary hospital and Yeoido St. Mary hospital
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bispecific antibodyIt 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 | Advanced Immuno-oncology Therapy Group |
| Antibody-Drug ConjugateIt 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 | Conventional Immuno-oncology Therapy Group |
| Monoclonal antibodyMonoclonal 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 | Conventional Immuno-oncology Therapy Group |
| Proteasome InhibitorIt 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 | Conventional Immuno-oncology Therapy Group |
| IMiD treatmentImmune 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 | Conventional Immuno-oncology Therapy Group |
| CAR-T TherapyIt 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. | Drug | Advanced Immuno-oncology Therapy Group |
Primary outcome
Quality of Lfe
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.
1 secondary outcome
Treatment Efficacy and Survival Outcomes
Time frame: From treatment initiation up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, Relapsed and Multiple Myeloma (MM), run by Sung-Soo Park at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sung-Soo Park, MD.PhD (+82-10-3782-2736, sspark@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Lfe (time frame: From treatment initiation up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.