Effect of HFR-SUPRA in the Treatment of Multiple Myeloma-related Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
In patients with multiple myeloma-related acute kidney injury, compare the renal outcome of chemotherapy combined with HFR-SUPRA to chemotherapy combined with hemodialysis.

Detailed Description
-----------------
In patients with multiple myeloma-related severe acute kidney injury, compare the renal outcome between patients receiving HFR-SUPRA and patients receiving hemodialysis. Both groups of patients receive chemotherapy.

Official Title
-----------------
Effect of HFR-SUPRA in the Treatment of Multiple Myeloma-related Acute Kidney Injury: a Prospective Cohort Study

Conditions
-----------------
Multiple Myeloma, Acute Kidney Injury, Hemodiafiltration With Ultrafiltrate Regeneration (HFR)

Intervention / Treatment
-----------------
* Procedure: HFR-SUPRA
* Procedure: hemodialysis
* Drug: Chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 80 years old new onset of multiple myeloma acute kidney injury with eGFR < 15 ml/min/1.73m2 and need hemodialysis biopsy-proven cast nephropathy or clinical diagnosis of cast nephropathy based on exclusion of other causes of acute kidney injury including post-renal obstruction, hypercalcaemia, amyloidosis, light-chain deposition disease, contrast media and drug nephropathy serum light chain > 500 mg/L Exclusion Criteria: chronic kidney disease stage 3 to 5 (eGFR< 60 ml/min/1.73m2 for at least 3 months) haemodynamics unstability active bleeding cardiovascular and cerebrovascular events in the last month other malignant tumor conditions not suitable to participate in the study, such as bad compliance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are divided into two groups: (1) chemotherapy combined with HFR-SUPRA (2) chemotherapy combined with hemodialysis
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFR-SUPRA<br>haemodiafiltration with ultrafiltrate regeneration by adsorption on resin (HFR-SUPRA) combined with chemotherapy. HFR-SUPRA everyday for 3 days, then 3 times per week. | Procedure: HFR-SUPRA<br>* HFR-SUPRA everyday for 3 days, then 3 times/week until patients do not require dialysis.<br>* Other names: haemodiafiltration with ultrafiltrate regeneration by adsorption on resin;Drug: Chemotherapy<br>* chemotherapy protocol will be made by hematologists.<br>|
| Active Comparator: Hemodialysis<br>hemodialysis combined with chemotherapy. Hemodialysis everyday for 3 days, then 3 times per week. | Procedure: hemodialysis<br>* hemodialysis everyday for 3 days, then 3 times/week until patients do not require dialysis.<br>Drug: Chemotherapy<br>* chemotherapy protocol will be made by hematologists.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| independence from dialysis at 90 days from allocation to groups | independence from dialysis at 90 days from allocation to groups | 90 days after allocation to groups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| independence from dialysis at 6 months from allocation to groups | independence from dialysis at 6 months from allocation to groups | 6 months after allocation to groups | 
| complete renal recovery at 90 days from allocation to groups | serum creatinine elevation≤ 0.2 mg/dl from baseline or serum creatinine ≤ 1.2 mg/dl if baseline level is unknown | 90 days after allocation to groups | 
| decline of free light chain at 21 days from allocation to groups | decline of free light chain from baseline level | 21 days after allocation to groups | 
| hematological remission at 90 days from allocation to groups | hematological remission at 90 days from allocation to groups | 90 days after allocation to groups | 
| hematological remission at 6 months from allocation to groups | hematological remission at 6 months from allocation to groups | 6 months after allocation to groups | 
| time to independence from dialysis | time to independence from dialysis | from allocation to groups to the last time of Hemodialysis or HFR-SUPRA | 
| survival at 12 months | survival at 12 months | 12 months after allocation to groups | 
| adverse events | adverse events | within the 3 months after allocation to groups |