Multiple Myeloma (MM)
Conditions
Interventions
experimental group:pomalidomide
Sponsors
The First Hospital of Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with primary diagnosis of symptomatic MM diagnosed according to the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (Revised 2020), aged >= 18 years; 2. Patients undergoing ASCT who have had prior induction therapy for no more than 12 months and whose disease has not progressed within 3 months of ASCT; 3. Patients who are not suitable for ASCT have reached maximum efficacy after induction and consolidation therapy; 4. Eastern Cooperative Oncology Group (ECOG) physical status score of 0-3; 5. Serum transaminase level was less than three times the upper limit of normal, serum total bilirubin level was less than 35umol/L, serum creatinine level was less than 177umol/L, neutrophil absolute value was greater than 1.0x10^9/L, and platelet count was greater than 75x10^9/L; 6. Patients of childbearing age are required to use two reliable methods of contraception simultaneously or have absolutely no sexual relations with the opposite sex for 4 weeks prior to initiation of treatment, during treatment, during suspension of dosing, and for 4 weeks after termination of treatment, and women of childbearing age agree to perform monthly pregnancy tests until 4 weeks after discontinuation of study drug; 7. Patients voluntarily enrolled in this study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients at high cytogenetic risk, defined as del(17p), t(4;14), t(14;16) detected by fluorescence in situ hybridization (FISH). 2. Patients who, in the judgment of the investigator, cannot tolerate pomalidomide treatment or are allergic to lenalidomide or thalidomide drugs. 3. Patients with a diagnosis of nonsecretory MM (meaning patients with completely nonsecretory MM or patients with a small amount of free light chain but with less than 100 mg/L of affected light chain). 4. With central nervous system involvement. 5. Patients with peripheral neuropathy >= grade 3. 6. Patients with known active hepatitis B virus (HBV-DNA >= 1x 10^3 copies/mL or HBV-DNA > 200 IU/mL) or hepatitis C virus (HCV), or serologically positive for human immunodeficiency virus (HIV). 7. Patients with concurrent other neoplasms or a prior history of neoplasms or antineoplastic therapy (including major surgery) within the last 4 weeks, except for the following neoplastic diseases or those who have lived tumor-free for >= 3 years to date: basal cell carcinoma of the skin, squamous epithelial cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histological findings of prostate cancer (TNM clinical stage T1a or T1b) or treated prostate cancer. 8. Patients with concurrent serious infectious disease. 9. Pregnancy or lactation. 10. Patients with active new-onset thrombosis or unwilling to undergo antithrombotic therapy. 11. Patients who, in the opinion of the investigator, are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission and very good partial remission; | — |
Countries
China
Contacts
Public ContactZhang Hao
The First Hospital of Lanzhou University
Outcome results
None listed