Multiple myeloma
Conditions
Interventions
Study Group:Selinexor and melphalan
Sponsors
Xinqiao Hospital, Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Aged18-75 years old; 2) Meet the diagnostic criteria of IMWG 2014 for symptomatic multiple myeloma, including newly treated and relapsed patients; 3) Willingness of autologous hematopoietic stem cell transplantation and efficient autologous hematopoietic stem cells; 4) Achieved =PR by induction or salvage treatment before transplantation but not reached CR; 5) Liver function meet the following requirements: Serum total bilirubin =1.5×ULN(Gilbert's syndrome =3 ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST)=2.5×ULN, ALT/AST=5×ULN for patients with liver infiltration and alkaline phosphatase = 5× ULN for patients with liver and/or bone infiltration; 6) Contraceptive methods in fertile patients within 3 months from the time of enrollment to the last medication. During the study period and within 3 months after receiving the last dose, do not donate ovum for the purpose of assisted reproduction; 7) Negative serum or urine HCG test of fertile female within 14 days before the first administration; 8) The subject or their legal representative voluntarily signs an informed consent form, indicating their understanding of the purpose and procedures of this study, and agreeing to participate in the study; 9) Obey the research plan and abide the taboos or restrictions stipulated.
Exclusion criteria
Exclusion criteria: 1) Not received =PR or disease progression during treatment after receiving previous treatment containing Selinexor or other nuclear export protein inhibitors; Or the disease recurs within 60 days after stopping using the nuclear export protein inhibitor; 2) Uncontrolled systemic or local infection; 3) Uncontrolled heart diseases, including myocardial infarction within 3 months before starting medication, or unstable diseases (unstable angina pectoris, congestive heart failure, new york Heart Association new function classification III-IV) related to heart function that can affect heart function; Uncontrolled arrhythmia (Grade 2 or above specified in the latest version of CTCAE), or clinically significant ECG abnormality. ECG examination in screening period showed that QT interval was > 470 ms; 4) HBsAg positive or HBsAg negative, but HBcAb positive and HBV-DNA copy number is higher than the normal upper limit of detection value; HCV antibody is positive, and the copy number of HCV-RNA is higher than the normal upper limit of detection value; 5) Known active human immunodeficiency virus (HIV) infection or HIV seropositivity; 6) Known intolerance, allergy or contraindication to Cellini or melphalan; 7) Unable to swallow, or has a history of gastrointestinal bleeding, inflammation, chronic diarrhea, known diverticulosis or having undergone gastrectomy or gastric banding that affects drug absorption. 8) According to the researcher's judgment, any active serious mental illness, medical disease or other symptoms/conditions that may affect treatment, compliance or the ability to provide informed consent; 9) May not be able to complete this study for other reasons or the researchers think that they should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of complete remission at 3 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematopoietic reconstitution time;Progressive free survival;The negative rate of MRD;Ratio of Best effect =CR;Objective response rate;Safety; | — |
Countries
China
Contacts
Public ContactGao Li
Xinqiao Hospital, Army Medical University
Outcome results
None listed