multiple myeloma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age above 18, regardless of gender; 2. According to the IMWG diagnostic criteria for multiple myeloma in 2014, the patient was diagnosed as symptomatic multiple myeloma and had measurable secretory disease, which was evaluated by the central laboratory and defined as any of the following: 1) IgG myeloma: serum M protein level = 10g/L or urine M protein level = 200mg/24h; 2) IgA, IgD, IgM or IgE myeloma: serum M protein level = 5g/L or urine M protein level = 200mg/24h; 3) Light chain type myeloma without measurable disease in serum or urine: serum free light chain = 100mg/L and abnormal ratio of serum free light chain; 4) Receive regular anti multiple myeloma therapy; 5) Women of childbearing age must have negative pregnancy examination before enrollment, and agree to use contraceptive measures during the study and within 3 months after the last treatment; 6) Ask for the informed consent of the subjects and their families, and sign the informed consent form voluntarily.
Exclusion criteria
Exclusion criteria: 1. Non active multiple myeloma, including primary amyloidosis, MGUS (monoclonal gammaglobulin disease of unknown significance) or smoking myeloma; 2. Non initial diagnosis and treatment; 3. Have a history of other malignancies except multiple myeloma within 3 years before screening (except for cured malignancies with a very low risk of recurrence within 3 years); 4. Psychotic subjects who are not easy to control; 5. Subjects who the researcher thinks are not suitable to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;To evaluate the impact of MRD-negative duration on survival in different subtype MM, such as the patients = 65 years or carrying HRCA.;To assess whether autologous hematopoietic stem cell transplantation (ASCT) or maintenance therapy prolongs the duration of MRD negativity; | — |
Countries
China
Contacts
The First Hospital of Jilin University