multiple myeloma
Conditions
Interventions
pomalidomide-based regimen group:Nil
Sponsors
Anqing Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years, male or female, diagnosed with multiple myeloma according to IMWG diagnostic criteria: (1) Treatment-na?ve multiple myeloma patients with high-risk factors defined as cytogenetic abnormalities (17p deletion, t(4;14), t(14;20), t(14;16)), myeloid external disease; (2) Patients with relapsed/refractory multiple myeloma. Refractory/relapsed is defined as: 1) Have never achieved minimal remission or above after receiving any treatment; 2) No response to salvage treatment or progression within 60 days after the last treatment; 3) The definition of clinical recurrence refers to the "Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma 2020 Revised Edition", and at least one of the following: new bone lesions or soft tissue plasmacytoma (except osteoporotic fractures); Measured lesion SPD increased by 50% and absolute value >= 1cm) increased existing plasmacytoma or bone lesions; hypercalcemia: > 2.75mmol/L; hemoglobin concentration decreased by >= 20g/L (not related to treatment or non-MM factors) ; Serum creatinine increased by >= 176.8umol/L (2mg/dl) from the start of MM treatment and was associated with MM; serum M protein-related hyperviscosity. (3) Definition of recurrence after CR, at least one of the following: 1) Immunofixation electrophoresis confirmed the reappearance of M protein in blood or urine; 2) The proportion of bone marrow plasma cells is >= 5%; 3) Any other manifestation of clinical progression (new plasmacytoma, osteolytic destruction, or hypercalcemia); The definition of disease progression refers to the "Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma Revision 2020", and at least one of the following (all the following data are compared with the lowest value obtained): serum M protein increased by >= 25% (absolute increase >= 5 g/L) or M protein increased >= 10 g/L (baseline serum M protein >= 50 g/L); urinary M protein increased >= 25% (absolute increase >= 200 mg/24h); if serum and urine M protein increased >= 25% If the protein cannot be detected, the difference between involved and non-involved serum FLC is required to increase by >= 25%, and the absolute value increase is greater than 100 mg/L; if both serum and urine M protein and serum FLC are undetectable, bone marrow plasma is required. The proportion of cells increased by >= 25% and the absolute value increased by >= 10%; new soft tissue plasmacytoma lesions appeared: more than 1 original measurable lesion SPD increased by >= 50% from the nadir; or the original >= 1 cm lesions Long-axis increase >= 50%; circulating plasma cells increase >= 50% (apply when only circulating plasma cells are measurable lesions, the absolute value requires at least 200 cells/µL); 2. Multiple myeloma patients judged by the investigator to benefit from pomalidomide-containing treatment regimens; 3. The patients voluntarily joined the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have had allergic reactions to pomalidomide or the ingredients contained in the drug; 2. Patients with active new thrombosis or unwilling to undergo antithrombotic therapy; 3. Patients who need long-term use of immunosuppressants or steroids; 4. Those who refuse to take reliable contraceptive methods during pregnancy, lactation or appropriate age; 5. The patient has other tumors at the same time or has a history of tumors, or has undergone anti-tumor treatment (including major surgery) within the last 4 weeks, except for the following tumor diseases: skin basal cell carcinoma, skin squamous cell carcinoma, cervical cancer Incidental histological findings of carcinoma in situ, carcinoma in situ of the breast, prostate cancer (TNM clinical stage T1a or T1b) or treated prostate cancer; 6. Patients suffering from central nervous system diseases and needing treatment; 7. Patients with peripheral neuropathy >= grade 3; 8. Severe mental illness; 9. Patients who are judged unsuitable for inclusion after the investigator's evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;Overall survival;Minimal residual disease; | — |
Countries
China
Contacts
Public ContactYao Fusheng
Anqing Hospital Affiliated to Anhui Medical University
Outcome results
None listed