Multiple myeloma
Conditions
Interventions
Experimental group:Daratumumab + carfilzomib + dexamethasone
Sponsors
First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Active (symptomatic) multiple myeloma (MM): (1) Bone marrow clonal plasma cell >=10% or paddle cell tumor confirmed by biopsy (2) Clonal bone marrow plasma cells in the bone marrow >=60%(S) (3) Serum free light chain ratio >=100 (Li) and involved free light chain >=100mg/L (4) MRI showing more than 1 focal lesion (M) (5) Hypercalcemia (C): blood calcium exceeds the upper limit of normal value of 0.25mmol/L or 10mg/dL; or blood calcium > 2.75 mmol/L or 110 mg/dL (6) Renal insufficiency (R): serum creatinine>177umol/L or 20mg/dL; or creatinine clearance =18 years old; 3) Multiple myeloma patients who are not suitable for transplantation and unwilling to transplant (1. Age> 70 years old, not suitable for transplantation; 2. Patients <=70 years old, but unwilling to transplant); 4) ECOG score 0-2; 5) Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1) Platelet count= 10×10^9/L 2) ANC= 500 pg/mL; 5) HIV-infected people (HIV antibody positive); 6) central nervous system involvement; 7) Patients with plasma cell leukemia; 8) the patient is allergic to daratumumab and carfilzomib or their components; 9) Patient has uncontrolled or significant cardiovascular disease, including myocardial infarction, class II-IV heart failure as defined by the New York College of Cardiology (NYHA), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis prior to enrollment; 10) Female patients are pregnant or lactating; 11) Concomitant other malignant tumors, infections that are not easy to control, serious physical illnesses or psychiatric illnesses that may interfere with participation in this clinical study; 12) Patients with severe autoimmune diseases or severe immunodeficiency; 13) Patients judged by the investigator to be unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival;Response rate at and above for hematologic VGPR;MRD conversion rate;Overall Survival,OS; | — |
Countries
China
Contacts
Public ContactShi Mingxia
The First Affiliated Hospital of Kunming Medical University
Outcome results
None listed