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An Observational Study to Evaluate Quality of Life, Safety, and Efficacy of Bispecific Antibody Administration in Combination with Tocilizumab in Patients with Multiple Myeloma.

Exploratory Observational Study to Evaluate the Quality of Life, Safety, and Efficacy of Outpatient-Based Prophylactic Tocilizumab Combination with Bispecific Antibody Administration in Patients with Relapsed/Refractory Multiple Myeloma.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0011665
Enrollment
30
Registered
2026-02-27
Start date
2026-06-09
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Tocilizumab: Administer 8 mg/kg intravenously or subcutaneously over 1 hour (maximum dose of 800 mg). May be repeated after a minimum of 8 hours, up to a maximum of 2 doses within a 24-hour per

Sponsors

The Catholic University of Korea, Seoul St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Male or female patients aged 19 years or older. 2)Patients diagnosed with Multiple Myeloma who have been previously treated with at least one Proteasome Inhibitor, one Immunomodulatory Agent, and one Monoclonal Antibody therapy (i.e., patients exposed to all three major classes of immunotherapies). 3)Patients diagnosed with Relapsed/Refractory Multiple Myeloma (RRMM) during the period from the IRB approval date until December 2025, and who are scheduled to initiate treatment with a bispecific antibody within one month of screening. 4)Subjects who have received a detailed explanation of this study, have voluntarily decided to participate, and have provided written informed consent to comply with the study requirements.

Exclusion criteria

Exclusion criteria: 1) Those who do not consent to participate in the study 2) Patients diagnosed with a plasma cell disorder other than multiple myeloma (e.g., lymphoma, POEMS syndrome) 3) Those who cannot read and understand documents written in Korean

Design outcomes

Primary

MeasureTime frame
the incidence and severity

Secondary

MeasureTime frame
the differences in dosing schedule and operational practices;the antitumor efficacy;quality of life and functional;the changing patterns of PRO;To compare the efficacy and adverse effects of standard-of-care (SOC) drugs with the same indications and dual antibodies.;Assess the association between immune and genomic biomarkers and clinical indicators.

Countries

Korea, Republic of

Contacts

Public ContactSeungMin Jun

The Catholic University of Korea, Seoul St. Mary's Hospital

jtmdals0621@naver.com+82-2-2258-6053

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Mar 14, 2026