Multiple Myeloma
Conditions
Interventions
experimental group:ixazomib+lenalidomide
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
19 Years to 70 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following conditions to be eligible for this study 1) Older than 18 years; 2) Diagnosis of active MM (according to imwg2014 standard of International Myeloma Working Group); 3) The stage of R-ISS was stage III (ß 2-microglobulin >= 5.5mg/dl + elevated serum lactate dehydrogenase or high-risk cytogenetics). The high-risk cytogenetics included t (4; 14), t (14; 16), del (17p); 4) With measurable parameter: serum protein electrophoresis showed M protein (SPEP) >= 10g / L, 24h urine light chain >= 200mg, or involved blood free light chain >= 100mg / L. For non secretory type, the number of bone marrow clonal plasma cells should be taken as the evaluation index, and the proportion of bone marrow plasma cells should be more than or equal to 30%; 5) Patients who have received autotransplantation and have not progressed more than once; 6) The expected survival is more than 3 months; 7) ECOG score <= 2; 8) No active infection; 9) Voluntarily participate in the clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria must be excluded from this study 1) With plasma cell leukemia, circulating plasma cells >= 2.0 * 10 ^ 9 / L or >=20%; 2) Combined with amyloidosis, histology confirmed the presence of amyloidosis; 3) Other malignant tumors diagnosed within 3 years in screening period; 4) Acute myocardial infarction within 6 months; 5) Thrombotic events within 1 month were combined; 6) Having previously received allogeneic transplantation; 7) Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR+VGPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;MRD negativity;Safety; | — |
Countries
China
Contacts
Public ContactLu Jin
Peking University People's Hospital
Outcome results
None listed