Relapsed and refractory multiple myeloma
Conditions
Interventions
Treatment group:For all trial subjects, the following drug administration regimen (Pyrotinib + Dexamethasone) is recommended for the initial treatment.
Pyrotinib: Administer 400 mg once a day, orally
Sponsors
The First Affiliated Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1)Age >= 18 years old, regardless of gender. 2)Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 - 3. 3)Life expectancy of more than 12 weeks. 4)According to the 2016 International Myeloma Working Group (IMWG) criteria, the patient is diagnosed with relapsed/refractory multiple myeloma and has measurable lesions, meeting at least one of the following criteria: 1) Serum M protein >= 0.5 g/dL (>= 5 g/L); 2) Urine M protein >= 200 mg/24 hours; 3) When the serum free light chain (FLC) ratio is abnormal, the level of the involved FLC >= 10 mg/dL (>= 100 mg/L). 5)The patient has received at least three treatment regimens for multiple myeloma and has refractory myeloma to at least one immunomodulatory drug (such as lenalidomide or pomalidomide), at least one proteasome inhibitor (such as bortezomib or carfilzomib), daratumumab, glucocorticoids, and their latest regimen. Refractory myeloma is defined as progression during treatment or within 60 days after the completion of treatment, or a response to treatment of less than 25%. As long as all other inclusion/exclusion criteria are met, there is no upper limit to the number of previous treatments. 6)Hemoglobin >= 6.0 g/dL (pre-transfusion of red blood cells or the use of recombinant human erythropoietin is allowed); Absolute neutrophil count >= 0.75 x 10?/L (the use of granulocyte colony-stimulating factor is allowed); Platelet count >= 50 x 10?/L (Blood transfusion is allowed to reach this minimum platelet count); Aspartate aminotransferase (AST) = 50%; 7)The patient voluntarily participates in this study, signs the informed consent form before screening, and is willing to follow and capable of completing all trial procedures.
Exclusion criteria
Exclusion criteria: 1)Smoldering multiple myeloma. 2)Plasma cell leukemia; 3)The subject has been diagnosed with or treated for other invasive malignant tumors other than multiple myeloma, except for the following situations: The subject has received radical treatment for a malignant tumor and has no known active disease for >= 3 years before enrollment; 4)The subject has clinically significant heart disease, including myocardial infarction within 6 months before the start of the study, unstable angina pectoris, New York Heart Association (NYHA) class III-IV cardiac insufficiency, or uncontrollable arrhythmia; 5)Human immunodeficiency virus (HIV)-infected individuals; 6)Pregnant women or subjects of childbearing age who are planning to become pregnant (including male subjects whose partners are planning to become pregnant); 7)Subjects with other uncontrolled diseases who, in the opinion of the investigator, are not suitable for enrollment; 8)Patients with three or more extramedullary lesions that are expected to be controllable by radiotherapy; 9)Any situation that, in the opinion of the investigator, may increase the risk to the subject or interfere with the test results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DOR;OS;ADR;Biomarker;The incidence rate of treatment-related adverse events and serious adverse events; | — |
Countries
China
Contacts
Public ContactZhiyong Zeng
The First Affiliated Hospital of Fujian Medical University
Outcome results
None listed