Multiple myeloma
Conditions
Interventions
Observation group:None
Sponsors
Beijing Chao-Yang Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Patients with newly diagnosed multiple myeloma according to the IMWG 2014 criteria; 2) Aged 18 to 80 years (as judged by the investigator based on the patient's actual physical condition); 3) Diagnosed with renal impairment, defined as eGFR = 10 g/L; urine M-component >= 200 mg/24 hours; involved blood free light chains >= 100 mg/L); 6) No history of chronic renal insufficiency within the past year; 7) ECOG performance status = 50 × 10^9/L within 14 days prior to enrollment; 10) Absolute neutrophil count >= 0.5 × 10^9/L within 14 days prior to enrollment; 11) Patients with < Grade 2 peripheral neuropathy within 14 days prior to enrollment; 12) No plasma exchange performed within one week prior to enrollment; 13) Selection of the treatment regimen of daratumumab combined with bortezomib and dexamethasone for induction therapy; 14) Patients who agree to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Although tubular nephropathy is present, it is a secondary lesion; renal impairment caused by other reasons is the primary lesion, including but not limited to renal amyloidosis and light chain deposition disease. 2) Patients have a history of allergy to daratumumab or any of its excipients and/or bortezomib. 3) Within the 6 months prior to enrollment, patients have uncontrolled or severe cardiovascular diseases, including myocardial infarction, NYHA Class II-IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis. 4) Female patients are pregnant or breastfeeding. 5) Presence of other malignancies, uncontrolled infections, severe physical illnesses, or mental illnesses that may interfere with participation in this clinical study. 6) Individuals who cannot understand or comply with the study protocol or are unable to sign the informed consent form. 7) During the study, women of childbearing age and men do not agree to use appropriate and effective contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Renal Response Rate at 3 Months(>= MR);Overall response rate;3 months after autologous transplantation or at the end of 9 courses of non-transplantation chemotherapy, if the efficacy reaches >= VGPR, the rate of minimal residual disease (NGF-MRD) conversion is evaluated;Overall survival;Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major renal response rate at 3 months(>= PR);Overall Renal Response Rate at 6 Months,12 months;Response rate at least VGPR; | — |
Countries
China
Contacts
Public ContactWen Gao
Beijing Chao-Yang Hospital Capital Medical University
Outcome results
None listed