Smoldering multiple myeloma (SMM)
Conditions
Interventions
Interferon treatment group:Ropeginterferon 500 µg, administered subcutaneously once every two weeks, for a total of 12 administrations, with a treatment period of 6 months.
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 or above and 80 or below. 2. Must meet the IMWG diagnostic criteria for Smoldering Multiple Myeloma (SMM); Based on existing research, patients must have a high risk of progression from SMM to active MM, satisfying any one of the following conditions:Serum M-protein quantification over 30 g/L, or Reduction in the levels of two uninvolved immunoglobulins (limited to IgG, IgM, or IgA), or The ratio of involved to uninvolved serum free light chain (sFLC) is over 8 and less than 100, or Clonal bone marrow plasma cell percentage is oover 50 and less than 60; 3. Must have measurable lesions, satisfying any one of the following:Serum M-protein quantification over 10 g/L,or 24-hour urine M-protein over 200 mg/d, or Abnormal sFLC ratio with involved sFLC over 100 mg/L; 4. ECOG score of 0-1; 5. Pre-enrollment screening laboratory tests must meet all of the following criteria:Absolute Neutrophil Count (ANC) over 1 × 10*9/L, and ALT or AST less than 2.5 times the upper limit of normal , and total bilirubin less than 2 times the ULN; 6. Clear understanding of the trial content, voluntary participation and completion of the trial, and voluntary signing of the Informed Consent Form; 7. Both males and females must strictly implement contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Complies with the diagnosis of active multiple myeloma. 2. Diagnosed with AL; 3. Being treated with interferon; 4. Being treated as Multiple myeloma; 5. Have other hematological malignancies or solid tumors; 6. HIV patients, or those with hepatitis B or hepatitis C, have been evaluated by a specialist and are currently deemed to require antiviral drug treatment. 7. Allergic to any component of interferon alpha or ropeg interferon alpha-2b, or who are currently taking medications that interact with interferons; 8. Patients with severe mental disorders or those with a history of such conditions, especially those suffering from severe depression, suicidal thoughts or attempts at suicide; 9. Patients with severe cardiovascular diseases, such as uncontrolled hypertension, congestive heart failure (NYHA classification greater than or equal to grade 2), severe arrhythmia, severe coronary artery stenosis, unstable angina pectoris, or those who have recently suffered a stroke or myocardial infarction; 10. Patients with a history of autoimmune diseases or those with concurrent autoimmune diseases who receive immunosuppressive agents or monoclonal antibodies, or patients who have undergone organ transplantation and are using immunosuppressive agents; 11. Patients who had undergone major surgery within two weeks prior to enrollment; 12. Women patients who are pregnant or breastfeeding, or those who have a planned pregnancy during the study period;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;Overall Survival (OS);Time to response, TTR;safety; | — |
Countries
China
Contacts
Public ContactZhuang Junling
Peking Union Medical College Hospital
Outcome results
None listed