Multiple Myeloma, Renal Injury
Conditions
Brief summary
Multiple myeloma (MM) is still an incurable hematological tumor, and renal involvement is the main factor of poor prognosis. The recovery of renal function can partially reverse its poor outcome. Although the 5-year survival rate of MM patients has significantly improved after entering the era of new drugs, patients with severe renal insufficiency still have a high early mortality.The purpose of this study is to investigate whether early intensive chemotherapy can reverse the proportion of renal insufficiency, is to investigate the treatment effect of RIMM patients with different renal pathological types, and is also to investigate whether autoHSCT can further partially save renal function in RIMM patients.
Detailed description
For patients with multiple myeloma with renal impairment, the same disease stage and the same treatment regimen have different therapeutic effects. In the era of new drugs, studies have shown that early reduction of the free light chain in serum is the key to reversing renal function. The International Myeloma Working Group recommends the following drugs for the treatment of RIMM patients: 1. regimens based on proteasome inhibitors; 2. regimens based on immunomodulators. Here, we explore a clinical study on the Whole-course Management (BCD-KPD-AutoHSCT) scheme for patients with RIMM.
Interventions
DRUGBortezomib
A reduction in serum FLCs level of more than 80% by day 14 of BCD is defined BCD-AutoHSCT group; A reduction in serum FLCs level of less than 80% by day 14 of BCD is defined BCD-KPD-AutoHSCT group.
Sponsors
Peking University First Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 years or older 2. Confirmed diagnosis of symptomatic myeloma with renal impairment 3. Confirmed myeloma-associated nephropathy (e.g. light chain cast nephropathy, AL amyloidosis, MIDD etc.) on renal biopsy 4. Willingness and eligibility for autologous hematopoietic stem cell transplantation
Exclusion criteria
1. Pre-existing chronic kidney disease unrelated to myeloma, such as diabetic nephropathy or hypertensive nephropathy 2. Plasma cell leukemia or extramedullary plasmacytoma 3. Contraindications or prior severe allergic reactions to study medications 4. Co-existing malignancy 5. Co-existing medical conditions unsuitable for enrollment as determined by researchers, such as recent cardiovascular event, active infection etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| renal response rates | 2 years |
Countries
China
Contacts
Primary ContactBo Tang, PhD.
Backup ContactYujun Dong, M.D.
Outcome results
None listed