Plasma-free Replacement in Patients With Multiple Myeloma

Sponsor

Zhongnan Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05251896

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate whether the technique of no plasma exchange is suitable for the treatment, clinical efficacy, safety, and suitability of multiple myeloma patients with M protein abnormality or renal failure.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Procedure: Plasma-free procedure	Phase 1

Detailed Description

Multiple myeloma (MM) is the second most common hematological tumor after non-Hodgkin's lymphoma. The tumor cells originate from plasma cells in the blood pulp and are classified as plasma cells blood myeloma plasmacytomas by the WHO Tumor. It is characterized by abnormal proliferation of blood medullary plasma cells, accompanied by monoclonal immunoglobulin or light chain. Few patients are classified as non-secretory MM that does not secrete M protein. Multiple myeloma is often accompanied by multiple hemolytic damages, hypercalcemia, anemia, kidney damage, and a serious threat to the patients' lives, health, and quality of life, which have brought a heavy burden to society. Large amounts of M protein pass through the kidneys. At times, it causes acute or chronic renal failure; M protein interferes with the activity of coagulation factors, blocking platelet function, inducing bleeding; and a large amount of M protein can also lead to hyperviscosity syndrome, increase circulatory resistance, and small blood vessel thrombosis Plug, cause various neurological diseases such as blindness, and further aggravate the progression of kidney injury. Patients with hematological myeloma nephropathy already existed at the time of diagnosis, severe patients may die due to renal insufficiency, so the patient was removed immunity globulin in the body to improve the signs of hyperviscosity and clinical symptoms is the focus of clinical research.

In this study, on the basis of previous studies, albumin-free plasma exchange fluid treatment was given to analyze the effects of clinical symptoms, erythrocyte sedimentation rate, blood routine, albumin, renal function, calcium content, and immunoglobulin.

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Efficient Method of Eliminating M Protein in Patients With Multiple Myeloma by Plasma-free Replacement

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Plasma-free procedure	Procedure: Plasma-free procedure Use albumin solution, lactated Ringer's solution, normal saline as replacement fluid

Arm

Intervention/Treatment

Experimental: Plasma-free procedure

Procedure: Plasma-free procedure

Use albumin solution, lactated Ringer's solution, normal saline as replacement fluid

Outcome Measures

Primary Outcome Measures

Change from M protein content in plasma at Week 18 [Day 0，Day 1，Week 1，Week4，Week 12，Week 18]
M protein content in plasma
Change from Blood routine in plasma at Week 18 [Day 0，Day 1，Week 1，Week4，Week 12，Week 18]
WBC
Change from Blood routine in plasma at Week 18 [Day 0，Day 1，Week 1，Week4，Week 12，Week 18]
RBC
Change from Blood routine in plasma at Week 18 [Day 0，Day 1，Week 1，Week4，Week 12，Week 18]
PLT
Change from Blood routine in plasma at Week 18 [Day 0，Day 1，Week 1，Week4，Week 12，Week 18]
Hb
Change from Blood routine in plasma at Week 18 [Day 0，Day 1，Week 1，Week4，Week 12，Week 18]
Sodium ion
Change from Blood routine in plasma at Week 18 [Day 0，Day 1，Week 1，Week4，Week 12，Week 18]
Potassium ion
Change from liver and kidney function at Week 18 [Day 0，Day 1，Week 1，Week4，Week 12，Week 18]
eGFR
Change from liver and kidney function at Week 18 [Day 0，Day 1，Week 1，Week4，Week 12，Week 18]
Creatine
Change from liver and kidney function at Week 18 [Day 0，Day 1，Week 1，Week4，Week 12，Week 18]
β2-MG
Change from liver and kidney function at Week 18 [Day 0，Day 1，Week 1，Week4，Week 12，Week 18]
UA
Change from liver and kidney function at Week 18 [Day 0，Day 1，Week 1，Week4，Week 12，Week 18]
ALB
Change from liver and kidney function at Week 18 [Day 0，Day 1，Week 1，Week4，Week 12，Week 18]
GLB
Adverse event: Low blood pressure [Day 1]
Low blood pressure
Adverse event: [Day 1]
Headache
Adverse event: Difficulty breathing [Day 1]
Difficulty breathing
Adverse event: Numbness [Day 1]
Numbness

Secondary Outcome Measures

Safety and Tolerability Assess patient symptoms [Day 0，Day 1]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of MM 2. A stable condition after routine treatment 3. Clinical diagnosis of renal insufficiency or M protein abnormalities 4．more than 18 years old 5．With liver and kidney function 6. With normal heart function; 7. Physical condition score 0-2 (ECOG score) 8. Get informed consent from the patient or family member.

Exclusion Criteria:

Allergies or obvious contraindications to any drug;
Myocardial infarction and cardiac insufficiency
Other malignant tumors
TB patients and HIV positive patients 5．Other blood system diseases
Pregnant or lactating women; 7. Not understand or follow the protocol; 8. Allergy