Plasma cell disease
Conditions
Interventions
queue A:daratumumab (8mg/kg) , bortezomib, and dexamethasone (DVd) regimen chemotherapy
queue B:daratumumab (16mg/kg) , bortezomib, and dexamethasone (DVd) regimen chemotherapy
Sponsors
Army Medical University Affiliated Daping Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 89 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for MGRS patients (Arm A): 1. Presence of monoclonal gammopathy by serum protein electrophoresis, Immunofixation, or Free Light Chain Assay; 2. Bone marrow flow cytometry suggests the presence of monoclonal plasma cells (0.5g and FLC of blood involvement>50 mg/dL must be met; 4. Soliciting informed consent from patients and their families, signing informed consent forms, and voluntarily participating in this trial;
Exclusion criteria
Exclusion criteria: 1. Under 18 years old; 2. Evidence of recent exposure to nephrotoxicity (non steroidal anti-inflammatory drugs, etc.); 3. Evidence of no obstructive kidney disease detected by ultrasound examination; 4. MGRS associated with diseases other than plasma cell dyscrasia (e.g. CLL, B-cell neoplasm, Waldenstrom's macroglobulinemia…),Plasma cell leukemia, or POEMS syndrome; 5. Previously received treatment for plasma cell clones; 6. Patients who cannot persist in two courses of treatment; 7. Failure to comply with predetermined treatment plans, follow-up, and research procedures; 8. Other situations that the researcher deems unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hematological remission rate;progression-free survival;Renal response rate; | — |
Countries
China
Contacts
Public ContactDongfeng Zeng
Army Medical Center
Outcome results
None listed