Multiple myeloma
Conditions
Interventions
Non-ASCT group:DKPD consolidation therapy
Transplant group:Autologous hematopoietic stem cell transplantation
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with newly diagnosed MM who meet the diagnostic criteria of the International Myeloma Working Group (IMWG) version 2014; 2. Meet the definition of HRMM and meet any of the following: (1) mSMART3.0 double strike or multiple strike: i.e. t(4; 14)t(14; 16)t(14; 20), at least two abnormalities of del 17p, p53 mutations, chromosome 1 abnormalities [1q21 acquisition/amplification and del(1p)]; (2) Extramedullary lesions confirmed by imaging or biopsy; (3) Meet the diagnostic criteria for plasma cell leukemia, that is, the proportion of peripheral plasma cells is greater than or equal to 5%; 3. Be over 18 years of age; 4. Have complete baseline assessment data and evaluable efficacy parameters: (1) Serum protein electrophoresis M protein quantification greater than or equal to 10g/L; (2) or 24-hour urine M protein >=200mg; (3) or the plasma free light chain ratio is abnormal, and the involved light chain >=100mg/L; 5. Creatinine clearance greater than or equal to 20ml/min; 6. Neutrophil count >=1×10^9/L, platelet count >=50×10^9/L; 7. Patients are allowed to receive no more than one course of bortezomib and/or lenalidomide and dexamethasone prior to entry into this study; 8. Clearly understand the content of the trial, voluntarily participate in and complete the trial, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.The patient had a history of allergy to carfilzomib and/or pomalidomide and/or daratumumab; 2.(NYHA) class III or IV; Or a left ventricular ejection fraction of less than 40%; 3.Uncontrolled angina, arrhythmia, or high blood pressure; 4.Myocardial infarction within six months; 5.Pericardial disease or cardiac amyloidosis; 6.Female patients were pregnant or lactating; 7.Other malignant tumors, difficult to control infection, serious physical or mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate;The negative rate of minimal residual disease after the completion of consolidation therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression free survival;Response rate above complete response;Response rate above very good partial response;Incidence of adverse effect; | — |
Countries
China
Contacts
Public ContactJunling Zhuang
Peking Union Medical College Hospital
Outcome results
None listed