None listed
Conditions
Interventions
None listed
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients aged 19 years and older.
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding women. Primary amyloidosis, smoldering multiple myeloma, or monoclonal gammopathy of undetermined significance (MGUS). Patients with a history of any malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix uteri, who have been completely treated within the past 5 years. Patients who experienced serious adverse events with Mezigdomide or drugs with a similar mechanism of action (e.g.,immunomodulatory drugs, IMiDs. Patients who experienced serious adverse events with previous treatment with a proteasome inhibitor (bortezomib, carfilzomib) or dexamethasone, making it impossible to continue administration of the drug. Patients with central nervous system involvement. Patients with active infection or uncontrolled serious concomitant conditions (e.g., uncontrolled heart failure, unstable angina, severe arrhythmia, active hepatitis B or C, HIV positive). Patients who are currently participating in another clinical study or have received investigational drugs from another clinical study within 30 days prior to enrollment. Patients deemed unsuitable for participation in the study at the investigator’s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR (Overall Response Rate): Response is defined as CR (Complete Response), VGPR (Very Good Partial Response), or PR (Partial Response) according to IMWG criteria, and the response rate will be calculated. | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS (Progression-Free Survival): The duration from the start of treatment to disease progression or death.;OS (Overall Survival): The duration from the start of treatment to death.;DOR (Duration of Response): The duration from the start of response to disease progression. | — |
Countries
Korea, Republic of
Contacts
Public ContactSeungmin Jun
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed