Multiple Myeloma
Conditions
Interventions
Trial Group:Standard preventive regimen + initial administration of IMIG (600 mg per dose, every 2 weeks)
Control Group:Standard preventive regimen + as-needed administration of IMIG (600 mg per dose, every 2 weeks, when IgG =3 infection occurs)
Sponsors
The Army Specialized Medical Center of the People's Liberation Army of China
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Diagnosed with symptomatic multiple myeloma (MM) according to the International Myeloma Working Group (IMWG) criteria, including patients ineligible for autologous stem cell transplantation (ASCT) and those eligible for ASCT who have already undergone transplantation and achieved hematopoietic reconstitution (white blood cell count >= 3×10^9/L); 2.Current treatment regimen includes an anti-CD38 monoclonal antibody, with a planned duration of therapy of at least 4 months; 3.Presence of hypogammaglobulinemia at enrollment, defined as a serum IgG level (corrected for M-protein) 6 months; 6.Voluntary participation with signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Age 3 seconds, or activated partial thromboplastin time prolonged by > 10 seconds); 5.Absolute neutrophil count (ANC) 30 g/L; 7.Current active infection (including bacterial, fungal, viral, or infection due to other pathogens); 8.Known history of immunodeficiency, including HIV-positive status or other acquired or congenital immunodeficiency disorders; 9.Concomitant second malignancy requiring treatment at the time of enrollment; 10.Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 11.History of psychoactive substance abuse or psychiatric disorders; 12.Poor compliance can easily lead to loss of follow-up; 13.Any other condition that, in the investigator's judgment, makes the patient unsuitable for study enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infection Incidence Rate within 4 months after enrollment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Grade >=3 Infection Incidence Rate and Cumulative Number of Infections within 4 months;Median Time to First Infection;Correlation between MM-related Infections and Lymphocyte Subpopulations (including B cells, NK cells, CD4+ T cells, and CD8+ T cells);Hospitalization Frequency and Duration Due to Infections; | — |
Countries
China
Contacts
Public ContactZeng Dongfeng
The Army Specialized Medical Center of the People's Liberation Army of China
Outcome results
None listed