extramedullary multiple myeloma
Conditions
Interventions
Test group:The combination of selinexor, bortezomib, lenalidomide and dexamethasone
Sponsors
The Second Affiliated Hospital Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients from 18 to 75 years old; 2. Newly diagnosed patients with multiple myeloma (MM) (IMWG consensus guidelines) and presenting with measurable extramedullary disease (EMD) of the skin, liver, lungs, lymph nodes or other tissues detected by physical exam and confirmed (when required) by CT/MRI/PET-CT and/or biopsy; 3. Patients having experienced two cycles of VRd (bortezomib, lenalidomide and dexamethasone) and gained a response = PR; 4. Patient must have measurable disease of MM as defined by the below criteria: a) Serum M protein level =5g/L (1.0 g/dL) or urine M protein level =200 mg/24 hours; b) Serum immunoglobulin free light chain (FLC) =100mg/L (10 mg/dL) and abnormal serum immunoglobulin kappa/lambda FLC ratio. c) measurable EMD =1 cm by CT/MRI/PET-CT; 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2; ECOG score of 3 as the consequence of MM is acceptable. 6. Adequate organ function within 7 days prior to C1D1 (supportive care is acceptable and enrollment will be decided by the investigator): a) Absolute neutrophil count (ANC) =1000/mm^3; Platelet count =50,000/mm^3; Hemoglobin =7.5 g/dL; b) Calculated creatinine clearance (using Cockcroft-Gault equation) =30 mL/min; c) Hepatic function defined as total bilirubin =2x upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) =2.5x ULN. As for patients with liver infiltration, AST and AST =5x ULN; 7. Voluntary written consent; 8. Reproductive Status: a) Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only; b) Women must not be breastfeeding; c) For both male and female participants, effective methods of contraception must be used throughout the study and for 7 months for female and 4 months for male following the discontinuation of study treatment.
Exclusion criteria
Exclusion criteria: 1. Active plasma cell leukemia. 2. MM involving the central nervous system. 3. Solely paraskeletal plasmacytoma (expanding soft tissue masses). 4. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to first dose. 5. Known active human immunodeficiency virus (HIV) infection or HIV seropositivity; known active hepatitis C infection; known hepatitis B virus DNA =1×10^3 copies/mL. 6. Known intolerance, hypersensitivity, or contraindication to any of the required concomitant drugs or supportive treatments. 7. Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| MRD negativity;CR;sCR;VGPR;PR;safety;PFS;OS;DOR;TTNT; | — |
Countries
China
Contacts
Public ContactYun Liang
The Second Affiliated Hospital Zhejiang University School of Medicine
Outcome results
None listed