multiple myeloma
Conditions
Interventions
case series:Nil
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with multiple myeloma (including extramedullary lesions) according to the diagnostic criteria for multiple myeloma; 2. Aged >= 18 years, no gender limit, if a patient of childbearing age should take effective contraceptive measures, and must agree to abide by all contraceptive requirements: 3. Relapse after receiving at least one treatment (including lenalidomide and bortezomib) in the past and ineffective to the last treatment (Definition of ineffective last treatment: multiple myeloma patients with disease progression during the use of this treatment regimen or within 60 days of using this treatment regimen, the last treatment regimen is not limited); 4. Multiple myeloma patients with measurable M protein, that is, at least one of the following 3 assays (except for extramedullary lesions): (1) Serum M protein >= 0.5g/dL (5g/L); (2) Urine M protein>=200mg/24h; (3) Determination of serum free light chain: in the case of abnormal serum free light chain ratio, the level of involved free light chain is >=10 mg/dL (100 mg/L); 5. Hematology meets the following conditions (except for extramedullary lesions): (1) ANC>=1.0x10^9/L (including ANC>=1.0x10^9/L under the support of G-CSF), plasma cells in bone marrow>=50%, and neutrophil count is not required; (2) Patients with PLT >= 50 x 10^9/L, plasma cells in the bone marrow >= 50%, and platelets >= 30 x 10^9/L can be selected; 6. Liver and kidney function tests meet the following conditions (except extramedullary lesions): TBIL=30ml/min; 7. Those who can accept and can use antithrombotic drugs, such as low molecular weight heparin sodium or aspirin; 8. ECOG score 0~2, expected survival period >= 3 months; 9. The informed consent has been signed. Informed consent was signed by the patient himself or his immediate family. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the legal guardian or the patient's immediate family will sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. According to the judgment of the investigator, patients who cannot tolerate the treatment of thalidomide, lenalidomide, pomalidomide and other types of drugs; 2. Patients who have had allergic reactions to immunomodulators similar to pomalidomide, dexamethasone or the components contained in the drug; 3. Diagnosis of non-secreting MM (referring to patients with no secretion at all or multiple myeloma patients (except extramedullary lesions) with a small amount of free light chains but the involved light chains are less than 100 mg/L); 4. Patients with active new thrombosis or unwilling to undergo antithrombotic therapy; 5. The patient suffers from other tumors at the same time or has a history of tumor or has undergone anti-tumor treatment (including major surgery) within the last 4 weeks; Except for the following neoplastic diseases: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histologic findings of prostate cancer (TNM clinical stage T1a or T1b), or treated prostate cancer ; 6. Patients with active central nervous system disease or history of central nervous system disease; 7. Patients with peripheral neuropathy >= grade 3; 8. Patients who need long-term use of immunosuppressants or steroids; 9. Known patients with hepatitis B virus (HBV-DNA >= 1x10^3 copies/ML) or hepatitis C virus (HCV) active stage, or human immunodeficiency virus (HIV) serology positive; 10. The patient has any of the following: (1) According to the NYHA classification standard, cardiac insufficiency grade 2 or above; (2) Myocardial infarction occurred within one year; (3) poorly controlled angina pectoris, including variant angina pectoris; 11. The patient is accompanied by serious infectious diseases; 12. Patients who plan to become pregnant or cannot take reliable contraceptive measures; 13. Women who are pregnant or breastfeeding; 14. Patients who have received allogeneic hematopoietic stem cell transplantation within 12 months, or patients with active graft-versus-host reaction disease (GVHD) or GVHD requiring immunosuppressive therapy after allogeneic hematopoietic stem cell transplantation for more than 12 months; 15. Those who have participated in other clinical trials within one month; 16. Those who are deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Very Good Partial Response Rate, VGPR;Complete Response Rate, CR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate,ORR;Progression-free Survival, PFS; | — |
Countries
China
Contacts
Public ContactLuo Jun
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed