Multiple myeloma
Conditions
Interventions
Study Group:Enrolled patients received continuous PVD therapy up to 9 cycles, including the first two 21-day cycles of pomalidomide (4mg oral on days 1-14), bortezomib (1.3mg/m2 subcutaneous on days 1
Sponsors
Beijing Chaoyang Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. According to IMWG 2014 standard, newly diagnosed patients with multiple myeloma; 2. Patients aged 18-80 years old; 3. Patients with renal insufficiency at diagnosis were defined as EGFR = 10g / L; Urinary M component >= 200mg / 24h; FLC >= 100mg / L); 7. There was no chronic renal insufficiency one year ago; 8. Patients with ECoG = 50 in 14 days before enrollment x 10^9/L; 11. The absolute neutrophil count of patients in 14 days before enrollment was >= 0.5 x 10^9/L; 12. The patients had peripheral neuropathy of grade < 2 within 14 days before enrollment. 13. Patients who had not undergone plasma exchange within one week before enrollment; 14. Patients who agreed to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with renal insufficiency caused by other reasons than tubular nephropathy, including but not limited to renal amyloidosis, light chain deposition disease, etc; The patient had a history of allergy to pomadomide or any of its excipients and / or bortezomib. 2. Patients with uncontrolled or severe cardiovascular diseases, including myocardial infarction, NYHA defined II-IV heart failure, uncontrolled angina pectoris, clinically significant pericardial disease or cardiac amyloidosis, within 6 months before enrollment. 3. Female patients during pregnancy or lactation. 4. Patients with other malignant tumors, uncontrollable infections, serious physical or mental diseases may interfere with the participation of this clinical study. 5. Patients who cannot understand, comply with the research protocol or sign the informed consent. 6. In the course of the study, women and men of childbearing age did not agree to take appropriate and effective contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal overall response rate at 3 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major renal response at 3 months;Renal overall response rate at 6 months;Renal overall response rate at 12 months;Hematological overall response rate;Hematological =very good partial response (VGPR) rate;Minimal residual disease (MRD);Progression free survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactWen Gao
Beijing Chaoyang Hospital Affiliated to Capital Medical University
Outcome results
None listed