Multiple Myeloma
Conditions
Interventions
Experimental group:Daratumumab plus bortezomib / cyclophosphamide / dexamethasone
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with confirmed multiple myeloma without treatment (according to the International Myeloma Working Group [IMWG]); 2. Aged 18-80 years; 3. renal insufficiency at diagnosis, Defined as eGFR = 5g / L; Urinary M component >= 200mg / 24 hours; FLC >= 100 mg/L) 5. Tubular nephropathy by biopsy or mainly judged by the investigators: urinary protein is mainly light chain, If the urinary albumin protein content is greater than 30% of the total urinary protein, Renal biopsy confirmation is required. 6. ECOG = 1.0×10^9/L, Platelet count >= 30×10^9/L 8. No serious organic lesions in the major organs (except for renal insufficiency caused by this disease), Meet the requirements of the following laboratory tests (within 7 days before treatment): 1) total bilirubin = 6 months;
Exclusion criteria
Exclusion criteria: 1 Previous systemic therapy with MM 2. eGFR <= 40 mL/min / 1. 73 m² over 3 months 3. Current clinically significant active cardiovascular disease, Such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional classification, Or a history of myocardial infarction within 6 months prior to screening; 4. Known Human Immunodeficiency Virus (HIV) infection; 5. Pregnant or lactating women; 6. Failure to understand, follow the study protocol, or fail to sign an informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal response rate after 4 courses of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Renal response rates at 6 and 12 months;Hematological response rate after 4 courses of treatment;3-year progression-free survival ;3-year overall survival;Safety; | — |
Countries
China
Contacts
Public ContactCai Zhen
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed